Manager Regulatory Affairs Resume Samples

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J Hilll

Jewel

Hilll

930 Karen Bypass

Detroit

+1 (555) 473 9182

930 Karen Bypass

Detroit

Phone

p +1 (555) 473 9182

Experience Experience

San Francisco, CA

Manager Regulatory Affairs

San Francisco, CA

Hand, Prosacco and Stehr

San Francisco, CA

Manager Regulatory Affairs

Willing to travel globally, including outside normal working hours. (appr. 10%)
Responsibility for the CMC change management for assigned development and marketed products, which includes providing regulatory assessments, tracking of CMC changes and processing of requests for related documentation(evaluation, consolidation, prioritization and review), responsibility for coordination of responses to health authority questions, and for implementation of CMC changes after HA approvals with product supply, to ensure regulatory CMC compliance
Manages work activities for members of the Regulatory Affairs team in both Calgary and Edmonton which may consist of regulatory specialists, advisors and analysts. This includes coordinating and facilitating the flow of work and advice, establishing objectives, priorities and standards through analysis and problem solving, managing performance, compensation and workforce planning, and performing related administrative functions
The incumbent will be responsible for supporting the US submission and monitoring submission timelines and timely responses to requests by competent authorities. It also includes constant development/ improvement of product development and RA processes
Assisting in preparing Regulatory Reporting around Appeals, Complaints and Grievances
Ensure compliance of both general and anti-money laundering and anti-terrorist financing (AML/ATF) compliance controls as well as operational risk controls in accordance with HSBC or regulatory standards and policies; and optimize relations with regulators by addressing any issues
Providing support for preparation of requested material and case files for review of External Auditor

Phoenix, AZ

Manager, Regulatory Affairs

Phoenix, AZ

Lehner Inc

Phoenix, AZ

Manager, Regulatory Affairs

Performs regulatory research to determine approval precedents, clinical development pathways, competitor program development
Provide assistance to the Associate Director on Sustaining project management
Manages and provides direction to a work group
Provides Regulatory leadership to direct reports by coaching, mentoring and providing development goals
Provide regulatory expertise and guidance for new product development and help develop regulatory strategies for the Americas
Provides regulatory support for diagnostic product development and commercial diagnostic products
Provides strategic regulatory interpretation of regulations and guidance documents to project teams from early development through post-approval

present

Boston, MA

Project Manager Regulatory Affairs

Boston, MA

Botsford-Cassin

present

Boston, MA

Project Manager Regulatory Affairs

present

Assist in the development of multicounty regulatory strategy and update strategy based upon regulatory changes
Build interface to external bodies, provide submissions and assist in audits
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Manage and execute preapproval compliance activities
Provide leadership by communicating and providing guidance towards achieving department objectives
Performs other tasks or assignments, as delegated by Regulatory management
Actively contribute to the development and functioning of the crisis/issue management program

Education Education

Bachelor’s Degree in Science

Belmont University

Bachelor’s Degree in Science

Skills Skills

Knowledgeable in FDA, EU and ICH guidelines relevant to CMC aspects of product development and maintenance
Ethical guidelines of the regulatory profession, clinical research and regulatory process
Strong attention to detail, establishing priorities, scheduling and meeting deadlines
Ability to work independently, take initiative and complete tasks to deadlines
Experience in directing interactions with regulatory authorities desirable
Professional certification desireable
Ability to adapt to home-grown databases
Experience with planning and preparing complex regulatory submissions for global filings to include, but not limited to the US (i.e., PMA, IDE, 510(k)) Europe and Japan
Strong knowledge of environmental, transport and safety regulations
Excellent communication skills – written and oral

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Manager Regulatory Affairs Resume Examples & Samples

The jobholder is required to work with considerable autonomy, dealing with major issues for which there is no clear cut solution whilst still being able to provide judgment and clear direction. Where items of major consequence are involved, reference is made to the senior management within RAP and where necessary, Heads of RC and FCC. The nature of the role requires close working contact with executives in HSBC Canada, and other Group companies as well as with members of the RC and FCC functions at all levels
The jobholder’s responsibilities cover all of HSBC Canada’s operations and will require work with RC and FCC function members in all Global Businesses and Functions
Some experience of regulatory and/or financial crime compliance would be an advantage
Knowledge or previous exposure to both regulatory and financial crime compliance risks and industry good practices would be an advantage
Knowledge of the HSBC Group structures its business and personnel, and an understanding of HSBC’s corporate culture would be an advantage
Experience with governance, risk and compliance workflow and repository systems would be an advantage
Excellent communicator with strong inter-personal and influencing skills
Ability to adopt a tailored and effective communication style to regulators at all levels of seniority and varying levels of management up to and including Group executive management
Organized and analytical approach

Manager Regulatory Affairs Resume Examples & Samples

Evaluation of manufacturing change controls, ensuring the assessment of regulatory impact and supporting their implementation
Regulatory assessment of manufacturing deviations
40Collaborate with US, EU & International regulatory colleagues in development of global CMC regulatory strategies
30Lead the preparation and filing of CMC sections of regulatory submissions providing CMC regulatory guidance to project / product teams and lead interactions with regulatory agencies
30Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, GMP investigations, gap analysis/remediation plans
Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in drug development and registration activities
Knowledgeable in FDA, EU and ICH guidelines relevant to CMC aspects of product development and maintenance
Ensures timely submission of appropriate regulatory documents in conjunction with Regulatory Operations
Must be highly organized, committed to excellence, and possess both determination and attention to detail
Must be self-motivated, able to respond effectively to changing priorities, and manage challenging assignments through collaboration, communication and teamwork
Strong attention to detail, establishing priorities, scheduling and meeting deadlines

Manager Regulatory Affairs Cmc-device Resume Examples & Samples

30% - Develop global CMC regulatory strategy and manage regulatory activities and timelines for one or more investigational and marketed products
10% - Collaborate with EU & International regulatory colleagues in development of global CMC regulatory strategies
30% - Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies
10% - Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines
10% - Provide CMC regulatory guidance to project / product teams
10% - Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Manager Regulatory Affairs Resume Examples & Samples

BS/BA Chemistry, Chemical Engineering or Environmental Science preferred
Professional certification preferred (CHMM, ASP/CSP, CIH)
Microsoft Office – Excel, Word, PowerPoint, Outlook
Ability to adapt to home-grown databases

Manager Regulatory Affairs Resume Examples & Samples

BA/B.S in a scientific, healthcare or related field or equivalent experience. Advanced degree preferred, but not required
Minimum of 8 years in drug/biologics development in the US pharmaceutical and biotechnology industry or Government Health Agency
Demonstrated track record of successful management of submissions in US regulatory affairs is required. Prior regulatory agency liaison experience is preferred
Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred

Manager, Regulatory Affairs Resume Examples & Samples

Tracking and ensuring the appropriate level of awareness of regulatory developments applicable to RBC securities registrants in Canada, within the business and various functional groups
Researching and responding to regulatory inquiries and investigations
Assisting with preparation and execution of regulatory filings
Providing periodic and ad-hoc internal reporting, including monthly reporting to Chief Compliance Officers and IssueTrack
Coordinating comments, drafting comment letters and making recommendations with respect to proposed comments for regulatory proposals with relevant stakeholders
Carrying out a gap analysis of policies and procedures upon the introduction of new decisions, rules, regulations, industry developments and enterprise initiatives and acting as a resource for business unit Compliance in amending its policies and procedures (including drafting policy recommendations or policies), as required
Coordination of external and internal audits
Identifying and managing cross-platform policy projects with the goal of ensuring a consistent approach to policies and procedures across RBC securities registrants, where possible
Where appropriate, participating in industry working groups; and
Special projects as assigned by the Director, Regulatory Affairs which may include projects outside of Capital Markets & Wealth Management Compliance (Canada) (enterprise Compliance initiatives)
Completion of industry courses (e.g. CSI courses); thorough knowledge of the Canadian securities regulatory environment (including CSA, IIROC, MFDA)
Good understanding of market structures and mechanics
Extensive experience developing and implementing policies and procedures
Ability to effectively manage a variable workload and prioritize work, multi-task responsibilities, perform under pressure and meet time-sensitive deadlines
Excellent communication skills – writing, verbal and presentation – including an ability to tailor communications for various audiences
High level of initiative, motivation and continuous improvement mindset
Ability to work independently and collaboratively, strong ethics and honesty essential
Understand and use technology: must be familiar with MS Word, Excel and Outlook and able to become proficient with new applications in a timely manner

Manager Regulatory Affairs Resume Examples & Samples

Ability to plan and manage multiple and competing priorities in a highly dynamic environment
Strategic thinker, detail-oriented and meticulous with an aptitude for analysis, investigation and problem solving
Excellent interpersonal skills; ability to gain credibility and establish strong relationships internally and externally
Ability to prepare and present cases to leaders, including risk assessment and recommended approach
Awareness of Ameriprise Financial products, services and technology/systems as well as supervisory structure preferred
Experience with e-Discovery software and large e-Discovery reviews/productions
The ideal candidate is self-motivated with the ability to achieve results as an individual contributor and working in a team-based environment
FINRA Registrations: Series 7 & 24 are strongly preferred for this role, but not required

Audit Manager Regulatory Affairs Resume Examples & Samples

Manages regulatory targeted examinations and ongoing supervision conducted by the Office of the Comptroller of the Currency (OCC), Federal Reserve Bank (FRB) and other regulatory agencies and Self-Regulatory Organizations (SROs)
Leads IA Compliance teams to identify, gather and produce responsive documents and information, and ensures that all responses are escalated, reviewed and approved
Apprises senior leadership of regulatory related metrics including the statuses of regulatory examinations, inquiries, document submissions and regulatory developments
Identifies and escalates to senior leadership issues raised during the course of regulatory exams, as appropriate
Anticipates potential regulatory issues and criticisms, and escalates to senior leadership, as appropriate
Drives the timely delivery of regulatory issue validations
Promotes the use of globally consistent communication tools, templates and presentations
Uses excellent communication, leadership and strong management skills to influence a wide range of internal audiences including respective product, function, or regional executive management partners and external audiences including regulators and external auditors
BA/BS or equivalent, preferably with a degree related to business, mathematics or statistics. Related certifications (CPA, ACA, CFA, CIA, CISA or similar) are a plus
6+ years of relevant experience in banking compliance, legal or other control-related function in the financial services industry
Broad understanding of multiple disciplines (AML, Risk, Compliance, and Culture and Conduct) and of different Internal Audit standards, policies and local regulations
Strong command of high risk areas including AML, Consumer Bank business, Investment Banking Division, Corporate functions, technology management, and program management
Specific subject-matter expertise regarding various regulations surrounding the Global Consumer Banking (GCB) business, including Fair Credit Reporting Act (FCRA), Flood Disaster Protection Act (FDPA), Truth in Lending Act (TILA), Equal Credit Opportunity Act (ECOA), Regulation AA, and Fair Housing Act
Effective negotiation skills, a proactive and 'no surprises' approach in communicating issues and strength in sustaining independent views. This individual must be an articulate and effective communicator, both orally and in writing, with an energetic, charismatic and approachable personality
Proficiency with PowerPoint, Excel, and Word is essential. Familiarity with SharePoint is a strong plus

Manager, Regulatory Affairs Resume Examples & Samples

Assures that existing and new products comply with all laws, rulings and regulations affecting the use of ingredients, labeling, advertising and other marketing materials
Provides guidance to brand and product development teams on new product concepts, claims and formulations to assure compliance with FDA, FTC, EPA and other state and Federal regulatory authoritative body's requirements while maintaining competitive positioning
Monitors the development and assesses the impact of new and proposed changes in laws, court rulings, lawsuits, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising. Communicates new requirements and changes within the organization, and assures compliance
Participates in and attends conferences of industry associations as assigned
Assists with the development of corporate policies and statements related to product safety, sustainability and ingredients
Works with Avon call center to monitor and analyze product-related customer complaints
Assists in the development of clinical trial protocols on behalf of the company, as deemed necessary
Bachelor Degree required, Master's degree preferred in a health related discipline such as biology, chemistry, pharmacology or public health
1-3 years experience in product development, safety or regulatory affairs in the consumer products industry
Reporting to Executive Director, Product Safety and Regulatory Affairs

Manager Regulatory Affairs Resume Examples & Samples

Working manager for the Global Business Unit (GBU) on labeling and nutrition
Communicates to the GBU an up-to-date knowledge of current country labeling regulations to include but not limited to product identity statements, ingredients/food additives, allergens and GE requirements
Assists in the development and communication of the company’s position
Must be able to sit for periods of time, up to 4 hours
Must be able to drive a company or rental vehicle for up to 5-7 hours or 300 – 500 miles

Manager, Regulatory Affairs Resume Examples & Samples

Directs and coordinates activities concerned with the submission/approval and reregistration of products to government regulatory agencies
Provide assistance to the Associate Director on Sustaining project management
Provides guidance to project team members regarding regulatory compliance issues
Regulatory Lead on all Department CAPAs
Provide Regulatory guidance to Compliance on PRAs, HHEs, and QRB decisions
Establishes accountability for the preparation of necessary metrics including outlines, summaries, status reports, memos, graphs, charts, tables, and slides
Interprets regulatory requirements and determines strategies to obtain clearances and approvals
Independently makes decisions regarding work processes or operational plans and schedule
Assigns projects or activities to individual contributors
A Bachelor’s degree within a technical related discipline and 8+ years relevant /regulated industry experience or Master’s degree with 6+ years relevant/regulated industry experience is required
Previous experience with medical devices is preferred
Demonstrated track record of developing and/or executing global regulatory strategies that align with business deliverables is required
A minimum 2 years of experience supervising staff by the way of direct reports or as a project lead is required
Experience contributing to work for regulatory bodies is required
Experience working with professional and trade associations is a plus

Manager, Regulatory Affairs Resume Examples & Samples

Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory agencies. Assist in the registration of products and product transfers to Wave 2 Countries
Oversees the preparation and maintenance of regulatory submissions and files for Wave 1 (US and EU) countries including US PMA submissions. Oversees process of obtaining data needed for Wave 2 Countries for China specific transfers
Provides leadership, personnel development, training, coaching, and mentoring for staff especially regarding US and EU regulations
Works with team members and partners to oversee the regulatory aspects of product transfers, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses for Wave 1 (US and EU) and Wave 2 Countries
Interprets regulatory requirements and determines strategies to obtain approvals for transfers and new product launches for products manufactured in China
Makes decisions regarding work processes or operational plans and schedules in concert with Business Wave 1 and Wave 2 Regulatory personnel
Previous US PMA experience is required
Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is preferred
Knowledge of International Regulations in China preferred

Associate Manager, Regulatory Affairs Resume Examples & Samples

Bachelor's degree or equivalent in Pharmacy, Life science or related discipline
Minimum 5 years of Regulatory Affairs experience in relevant healthcare industry
Excellent verbal and written communication skills - proficiency in written and oral English is required
Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others
Demonstrated ability to handle multiple projects
Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor
Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required
Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment
Proactive team player, able to take charge and follow-through.Regulatory Affairs

Manager Regulatory Affairs Resume Examples & Samples

Lead and manage activities concerned with the submission and approval of products to government regulatory agencies including global strategic markets, U.S. and Europe
Lead and manage a team with a focus on registering products in China, Japan, Brazil and Russia
Oversees the preparation and maintenance of regulatory submissions and files. Oversees process of obtaining data needed for global strategic markets
Provides leadership, personnel development, training, coaching, and mentoring for staff
Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products
Works with team members and commercial partners to oversee the regulatory aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses
Independently makes decisions regarding work processes or operational plans and schedules
Ensures organization compliance with all applicable regulations and J&J policies
Provides day-to-day instructions and suggested training activities to direct reports (if any)
Manages and provides direction to a work group
Expert in US, EU and International Regulations
A minimum of a Bachelor’s degree with 8+ years of relevant /regulated industry experience or Master’s degree with 6+ years of relevant/regulated industry experience is required
Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required
Leadership experience is required. Direct people management experience is preferred
Knowledge of International Regulations in China, Japan, Brazil and Russia preferred

Manager, Regulatory Affairs Resume Examples & Samples

Provide oversight, strategic planning and effective management for the growing and evolving Global Regulatory Operations function which includes but is not limited to regulatory submission publishing, systems, and tracking
Manage and oversee staff from Global Regulatory Operations team, which supports submissions publishing, archiving, database maintenance, license tracking tools, and other activities as assigned
Manage objective setting, contributes to career development plans, and skill development for direct reports and ensure appropriate performance assessment
Contributes to Global Regulatory Operations strategy, resource needs and allocation to ensure quality and timely submissions
Ensures compliance with SOPs. Supports and contributes to the development of new SOPs, or best practices for global regulatory operations and contributing functional areas
Works with Regulatory Affairs and contributing functional areas in establishing submission plans
Oversee the preparation and production of Regulatory Submissions globally using internal & external resources
May serve as a regulatory operations representative on cross-functional teams
Monitor and provide insight into new guidances relevant to regulatory operations
Bachelor’s degree or higher in a relevant technical or scientific field is required
5+ years of experience with regulatory submissions and project coordination is required
Experience with electronic document management software (e.g. Documentum), and related technology is required
Familiarity with MS Access, MS Project, MS Visio applications, and XML and SQL specifications is preferred
Working knowledge of Agency regulations and industry standards pertaining to regulatory operations is required
Demonstrated understanding of the drug or medical device development process is highly preferred
Management of talent, either direct or through an outsourced model is highly preferred
Must be fluent in English, both written and verbal

Manager, Regulatory Affairs Resume Examples & Samples

Plans, develops and applies regulatory strategies that permit the successful pre-market submissions of products worldwide
Identifies, develops, implements, and maintains innovative processes that promote efficiency change control and for worldwide registrations
Reviews and analyzes ECRS, NCs, manufacturing changes, design, and manufacturing protocols and documents
Manage lifecycle management activities such as CAPAs, labeling, audit preparation and support, promotional and advertising review, technical file/design dossier updates
Participate and provide regulatory guidance and support to cross-functional teams
The position will require interaction with the US.FDA, and with other regulatory authorities around the world
This position will include participation on New Product Development (NPD) teams to provide regulatory guidance and to obtain rapid and timely clearance of new products
Review and analyze technical data generated by Research and Development, Marketing/Sales, Quality Assurance and other related departments
Evaluate changes in regulatory environment and standards
Conduct gap analysis and implementation plans to assure compliance to latest requirements
Successful experience taking a product through the development and regulatory cycle domestically is required
Successful experience taking a product through the development and regulatory cycle internationally is preferred
Experience with multi-site organization is preferred
Global regulatory affairs and compliance experience is desired
Direct experience with global regulatory submissions is desired
Proven leadership and project management skills are desired
A successful track record coordinating and interacting with multiple cross-functional teams is desired
Travel may require up to 10% international and domestic travel, as needed
A Bachelor's degree and a minimum of 5 years of regulatory affairs experience in the medical device space is required
A Bachelor's degree in a scientific discipline and an advanced degree / RAC is desirable
Experience working with professional and trade associations is a plusRegulatory Affairs

Manager, Regulatory Affairs Resume Examples & Samples

Define and coordinate UDI and xUDID implementation activities and initiatives – including data collection, maintenance and submission activities
Develop and implement effective xUDID data collection and maintenance processes and infrastructure and provide ongoing Regulatory Support to IT and cross-functional project and product teams as US and Global UDI databases are implemented
Effectively assess impact of emerging global labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance
Establish appropriate cross-functional partnerships within RA and other functions to drive key global labeling strategies and initiatives
May provide direct supervision of individuals
Sound basis of global regulatory knowledge. Expert device labeling requirements and implementation will be an advantage
Ability to manage complex projects and timelines in a matrix team environment. Strong project management and organizational skills
Demonstrated interpersonal skills including strong negotiation and facilitation skills

Project Manager, Regulatory Affairs Resume Examples & Samples

Serves as RA representative on project teams
Manages RA project responsibilities and goals, coordinates the collection of data and information for regulatory submissions; writes the required regulatory submissions for new BAS products
Makes preliminary determinations regarding the appropriate US and/or International regulatory submission requirements for new or modified products
Reviews and approves documentation Change Requests, labeling artwork changes, recall and FDA inspection assistance, as defined by Bard corporate and BAS procedures
Coordinate the preparation of International Dossiers with the Product Teams and disseminate the dossiers to the appropriate parties
Keeps knowledge of FDA and/or global requirements current by attending industry, FDA, and corporate seminars, when possible
Alternate liaison for quality system audits and inspections
Develops BAS domestic and international Regulatory strategies
Supervises maintenance of US, CE and international documentation
Travel up to 10%
Bachelor's Degree in Life or Engineering Science, Business, or equivalency
Eight years regulatory affairs experience or equivalency, or six years with post-graduate degree
Regulatory experience in premarket notification submissions to FDA, 510(k) compliance, and international Regulatory Affairs decision making
Demonstrated communication and human relation skills
Excellent understanding of implementing US, CE and international regulations
High scientific, analytical evaluation skills
Good motivation skills
Good managerial/supervisory skills

Manager, Regulatory Affairs Resume Examples & Samples

Contributes to and leads in the preparation of regulatory submissions such as ANDAs, DMFs, NDAs (505b(2)), Supplements, Annual Reports
Reviews and approves changes made to pending and approved applications
Reviews and provides input into updating regulatory processes to ensure accuracy and compliance
Supervises regulatory activities to deliver timely results
Provides Regulatory leadership to direct reports by coaching, mentoring and providing development goals
Ensures policies and practices are reviewed and revised as needed
Uses standard programs and systems, ensures accuracy and completeness of regulatory submissions, filings and filing systems
Ensure department databases and filing systems for regulatory submissions are current
Identifies potential issues and resolves routine problems
Prioritizes work and receives general supervision and detailed instruction on new projects
Uses judgement and policies to reach solutions
Understands all company practices and interfaces with many management levels
Viewed as a technical resource internally
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.)

Manager, Regulatory Affairs Resume Examples & Samples

Responsible for preparation/supervision of preparation of regulatory submissions, including INDs, NDA, supplements, amendments, and variations
Responsibilities will include interaction with FDA and other regulatory agencies throughout the development of projects, including support for regulatory agency meetings, teleconferences, Advisory Committee meetings, etc
Production of associated records of regulatory meetings will be required along with the preparation of briefing documents
This individual will also be responsible for researching and the review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies to support the successful submissions and achievement of target product labeling
Identify and evaluate complex problems where analysis of situations or data requires an in-depth evaluation of various factors
Experience with 505(b)(2) submission required
Experience with bio-similar submissions is highly desirable
Participate in due diligence activities for potential licensing and acquisition opportunities that are being evaluated by the company
5-7 years regulatory or related experience in the pharmaceutical industry strongly preferred

Associate Manager, Regulatory Affairs Resume Examples & Samples

Monitor proposed and current global regulations and guidance; advise on impact of such regulations and guidance on the company within the scope of assigned project(s)
Will interact directly with Regulatory Agencies under management guidance
Responsible for regulatory promotional material, labeling content, product and process changes, and product documentation; analyzes and recommends appropriate changes
Will work directly with key stakeholders in our manufacturing plants in Puerto Rico and Dominican Republic reviewing proposed changes and providing regulatory guidance
Communicate and maintain productive constructive relationships with Edwards Lifesciences external customers as required – US FDA, distributors, third-party in-country regulatory representatives, and notified bodies
Perform other duties as assigned by the Sr. Director Regulatory Affairs
Bachelor’s degree required. A degree in Biomedical Engineering, another Engineering discipline, Marketing, or a Science is strongly preferred
Requires a minimum of 8 years Regulatory Affairs experience
Experience with IDEs, PMAs and/or 510(k) medical device products required
Experience writing FDA submissions required
Strategic thinking and problem solving capabilities is required
Ability to influence others at all levels of the organization is essential
Well-versed in program and project management, and new product development best practices
Project management certification is a plus
Direct and matrix supervisory experience a plus
Requires the ability to travel 20% of the time (domestic)

Manager, Regulatory Affairs Resume Examples & Samples

Prepares document packages for submission to global regulatory agencies (IDEs, PMAs, annual reports, 510(k)s and CE marking design dossiers and technical files)
Prepare IDE and PMA annual reports as well as Justifications to File
Act as liaison with government officials in support of product approvals
Exercise independent judgment in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents
Ensure schedules and performance requirements are met
Manage and mentor more junior members of the Regulatory Affairs team
Requires a minimum of ten years experience in Regulatory Affairs. Medical device experience in other areas may be considered
Experience in developing new product registration/dossiers for domestic FDA and EU product submissions is required
A Bachelors degree is required, preferably in a scientific discipline
Demonstrated competence in working as part of a focused project team
Experience in the cardiovascular device space is highly desirable
Requires familiarity with new product development systems; a strong working knowledge of all U.S. regulations that affect Class II and Class III devices; a strong understanding of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability

Manager, Regulatory Affairs Resume Examples & Samples

Interpret and apply regulations by creating regulatory strategies for EMEA markets
Define, monitor, collate, and publish deliverables for submissions in coordination with divisional RA teams
Participate in regulatory submission teams
Write and/or edit submission documents using regulatory templates, or create new templates
Participate on manufacturing transfer teams as regulatory representative
Review and approve advertising and promotional materials for regulatory compliance
Ensure health hazard assessments are performed for regulatory reporting of product problems
Prepare and review regulatory agency information packages and submissions
Interact with regulatory agencies
Participate in Material Review Board and complaint/recall meetings
Assess and approve labelling, process, and procedures changes for regulatory impact and ensure maintenance of regulatory compliance
Provide recommendations on labelling, manufacturing, analytical, and clinical study plans for regulatory compliance
Advise and guide management and other personnel in other departments on the interpretation and application of regulations
Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives. Assess impact and disseminate throughout the organization for continued regulatory compliance
Develop staff skills, abilities, and experiences for succession
Bachelor or equivalent in biological sciences, life sciences or related discipline with the required skills, knowledge and abilities that are typically acquired through extensive experience in the in vitro diagnostics, medical device or pharmaceutical industries; with a wide breath of Regulatory roles
Must have advanced knowledge of applicable regulations and standards
Ability to independently plan, execute, and/or problem solve moderate to complex situations
Must demonstrate initiative, balanced assertiveness working as a team player
Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel

Manager Regulatory Affairs Resume Examples & Samples

Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in an a timely manner
Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits
Identify as early as possible, the required documentation and any content, quality and/or timeline Negotiate the delivery of approved technical source documents in accordance with project timeline
Support or manage (with minimum supervision) interactions with FDA and other health authorities on CMC issues
Provide regulatory support to other Valeant functions during Regulatory Authority inspections
Serve as Regulatory Affairs representative on facility/site Local Change Management Boards
Participate in assigned due diligent business activities
Formulate, lead and drive CMC regulatory strategy with minimum supervision for development and marketed products. Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission). Support or manage with minimum supervision FDA or other Health Authority interactions on CMC issues
Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations
Knowledge of current and emerging issues and trends of the pharmaceutical regulatory environment
Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business
Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate in product development and post-approval activities
Ability to influence and partner with cross-functional teams
Ability to take innovative ideas from proof of concept to promote a successful product regulatory CMC submission and increase probability of regulatory approval
Self-motivated, detail-oriented and capable of working independently
Strong interpersonal skills with the ability to influence others in a positive and effective manner
6+ years pharmaceutical industry and 3+ relevant regulatory CMC experience
Bachelor’s degree in science, bio-chemical engineering, pharmacy or other health related field

Manager, Regulatory Affairs Resume Examples & Samples

O Responsible for implementing product regulatory strategy and operational activities for Rx products
Knowledge of prescription pharmaceutical products industry applicable to regulatory affairs discipline throughout the Rx product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
Knowledge of domestic and international laws, regulations, and guidance that affect Brand products
Knowledge of clinical development, including responsibilities for successful management of regulatory accountabilities for IND and/or marketing authorization, meeting facilitation, labeling negotiations, and handling of regulatory responses
Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products
Ability to influence and partner with cross-functional teams in a pharmaceutical organization
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
4+ years relevant pharmaceutical industry and regulatory experience
Pharmaceutical brand experience highly preferred

Manager Regulatory Affairs Resume Examples & Samples

To maintain the current marketing authorizations of Abbott BV in the Netherlands according to current regulatory standards, to ensure business continuity: preparation and submission of applications for variations, review and approval of local labeling documents, in cooperation with global (regulatory) functions of both Abbott and Mylan
To act on behalf of Abbott BV as principle contact to the regulatory agency in the Netherlands for the concerned products, or for other Abbott products and / or projects, as well as to Mylan
To ensure that the concerned products of Abbott BV in the Netherlands continue to comply to current regulatory standards
For Abbott’s influenza vaccine portfolio, to support the affiliates with applications for marketing authorizations, renewals, annual updates and variations, as well as for any other request for regulatory support, if this is to be provided by Regulatory Affairs Vaccines, Weesp
Principle contact, on behalf of Abbott BV and Mylan (Netherlands)

Project Manager, Regulatory Affairs Resume Examples & Samples

Advertising and promotion
Labeling
Compendial / standards
Import / export
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Domestic and international regulatory guidelines, policies and regulations
Communication Skills or Ability to
Plan and conduct meetings
Cognitive Skills or Ability to
Create project plans and timelines
Must be able to juggle multiple and competing priorities
Has broad knowledge of various technical alternatives and their potential impact on the business
Possesses ability to define regulatory strategy
Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues

Manager Regulatory Affairs Resume Examples & Samples

Long-standing experience of working in a regulatory environment
Life sciences degree (e.g. pharmacy, biology, medical)
Information Officer ("Informationsbeauftragter") according to AMG
Good communication skills, both verbal and written
The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
Good project management skills essential
Very good English language skills

Manager, Regulatory Affairs Resume Examples & Samples

Develop local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelines
Ensure Japan submission requirements are communicated to relevant regional and global support team
Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant
Inform group manager of Regulatory Affairs and New Product Information (NPI) team of progress of applications and issues impacting local applications
Assist with major submissions to register NCEs or new indications for existing products when needed
Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures
Manage interactions with PMDA and MHLW and maintain a productive working relationship
Participate in / coordinate special project assignments as determined by the Director of Regulatory Affairs
Support to the commercialization of products through participation in local NPI brand teams
Educate and train regulatory strategy to the staffs
Bachelor’s Degree in Pharmacy and preferably a licensed pharmacist
Understands business needs and impact of regulatory issues

Manager, Regulatory Affairs Immunology Resume Examples & Samples

Contributes to the execution of development & submission strategies in EU for projects assigned
Contributes to the assessment of the pros, cons & risks associated with regional strategic options for projects assigned
Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, e.g. Global Project Team as requested
May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues & may participate in global regulatory therapeutic area (TA) team
May develop or contribute to the development of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, MAAs & variations), ensuring compliance with regulatory requirements
Develops content of regulatory documents working with other functions as necessary & contributes to the review of documents before submission
Reviews draft protocols, acts as Regulatory Project Team representative in clinical study teams & liaises with the Clinical Trials Applications (CTA) group
May act as subject matter expert on designated studies in the event of a Health Authority inspection
Responsible for the delivery of Content Plans to allow publishing & timely dossier submission
Responsible for tracking & communicating regulatory activities within RA & responsible for accurate submission plans in eQRMS
Identifies & communicates to manager, any emerging issues that may impact Celgene’s business
May participate in interactions with Regulatory Authorities, including agency meetings
Supports the optimisation of product information achieved through negotiation with internal stakeholders & Regulatory Authorities
Supports activities to ensure that Celgene fulfils Health Authority commitments
May participate in regional launch team
May be responsible for the regulatory review & approval of commercial advertising & promotional literature
Highlights resource constraints through discussion with manager
Identifies any learning or best practice & communicates to manager
Responsible for maintaining knowledge of current EU regulatory guidance & procedures
International travel may be necessary
Bachelor’s degree in scientific discipline or equivalent required
Experience in EU Regulatory Affairs & recent experience of EU Centralized Procedure required
Good understanding of current regulatory requirements essential
Good understanding of CTD modules; non-clinical, CMC, Clinical
Developing understanding of TA for projects assigned
Experience in Inflammation/ Immunology preferred
Able to contribute to Ph III protocols & clinical development plans
Takes initiative for professional development
Effective project manager. Prioritises tasks appropriately. Able to & coordinate the delivery of multiple projects
Ability to lead routine regulatory submissions. Leads activities for assigned projects
Demonstrates appropriate decision making
Displays a willingness to challenge the status quo & take risks & acknowledges others who take the initiative to try new approaches even if the results are not perfect
Can identify when to escalate issues to line management & knows when to seek advice
Communicates effectively with Regulatory Authorities when tasks have been delegated
Obtains alignment through effective communication

Manager, Regulatory Affairs Strategy Resume Examples & Samples

B.S. degree, preferably in a scientific discipline
Prefer an advanced degree (e.g., Masters, Pharm.D., Ph.D.)
Experience in the pharmaceutical industry required with 2+ years direct regulatory affairs experience

Manager, Regulatory Affairs Resume Examples & Samples

Responsible for developing a product regulatory strategy for surgical devices
May liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
Develop a product regulatory timeline aligned to Bausch & Lomb’s/Valeant’s product development, with key regulatory milestone, and activities for agency filing
Ensure labeling content and product documentation is developed in accordance with regulatory requirements
Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities
Act as a regulatory contact for assigned country Regulatory Authorities for surgical devices
Prepare and submit regulatory submissions for US and EU product registrations
Manage interactions with other Bausch & Lomb/Valeant functions (e.g., Quality, Compliance) during Regulatory Authority inspections
Manage assigned personnel as applicable

Manager, Regulatory Affairs Resume Examples & Samples

Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures
Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and subteams
Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
Maintains knowledge of highly complex regulatory requirements up to current date, contributes to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management
Initiates or contributes to local and/or global process improvements which have a significant impact on business
Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business
Must be capable of developing and implementing regulatory strategies and of managing complex negotiations with regulatory authorities
Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
Must be capable of critically reviewing complex technical documents and influencing colleagues across functions
Must be capable of effectively leading teams in preparation of submissions
Schedules and arranges own activities and those of direct reports
Work is performed under direction of a Senior Regulatory Affairs professional

Manager, Regulatory Affairs Resume Examples & Samples

Generate and/or submit filings/registrations including
Regulatory and technical abilities
Experience in patient monitor systems, hospital-based products, software or electronic device products
Experience with the product safety testing process such as electrical safety, EMC and wireless testing
Experience interacting with regulatory bodies, such as the FDA and Notified Body
Knowledge of harmonized standards, such as IEC/ISO standards

Manager, Regulatory Affairs CMC Resume Examples & Samples

Manage the preparation and review of new Abbreviated New Drug Applications and amendments and supplements to ANDAs for upper management review. Manage data and information including monitoring submission schedules for adherence to deadlines for Product Development and Chemistry
Oversee internal and external reviews of new Abbreviated New Drug Applications
Prepare amendment responses to FDA comment letters. This includes circulating comment letters for review and scheduling meetings to discuss response(s) and explain deadlines to other departments such as Product Development, Chemistry and Purchasing
Manage pending ANDAs including ensuring that all regulatory requirements and/or commitments are met with respect to obtaining approval of new products and tracking changes to ensure that any additional information or revised documentation are submitted
Manage ANDAs post-approval including performing thorough reviews of Annual Reports to ANDAs and serving as the sign-off to the 2252 form for upper management
Manage employees by serving as a mentor and providing direction to direct reports including scheduling and distributing the regulatory workload, answering questions and providing guidance. Also monitor direct reports to ensure quality performance and provide performance feedback
Provide regulatory advice and coaching on ANDA submissions, approval and post-approval processes to Product Development, Quality Assurance, and Quality Control
Review internal documentation such as change control information, method transfer packages, batch record documentation, validation protocols and reports
Maintain current knowledge of regulations and other issues that affect products and the industry. Disseminate and discuss with appropriate staff in a timely manner
Minimum of a Bachelor's degree (or equivalent) and 4-6 years of relevant experience. A minimum of eight years of experience in the pharmaceutical industry and a degree in science is preferred. However, a combination of experience and/or education will be taken into consideration
Must possess expert-level knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations and various FDA Guidances for Industry and have the ability to interpret these to apply to Mylan procedures. Must also possess expert-level knowledge of the regulatory process pertaining to drug development, registration, review and approval. Must possess knowledge of Mylan’s approach with regards to interactions with the FDA
Must possess strong analytical, organization, writing, and communication skills. Must have the ability to multi-task and have meticulous attention to detail. Must possess strong computer skills and working knowledge of Microsoft Office Suite, Documentum, and Lotus Notes. Must be able to manage various projects and employees in order to meet submission deadlines
Position functions autonomously. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Ability to perform computations such as percentages, ratios, and rates
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements

Manager, Regulatory Affairs Resume Examples & Samples

Coordinate activities, define timing, and create registration files to support new product registrations as well as maintanence of approved biologicals, pharmaceuticals, bio-pharmacueticals, or other regulated products in CALAR markets
As the CALAR regulatory member on product development teams, provide strategic, proactive, and timely regulatory expertise specific to the planning, requirements, and execution of the project
Liaise with Reg CMC, VMRA, GMS, CDLCI and other partner groups to support the definition of regulatory strategy and action plans for the registration and introduction of new biologicals and pharmaceuticals in CALAR markets
Provide guidance on VMRD processes and Zoetis policies to all iCRAMS located in CALAR markets
Plan, prepare, coordinate and execute clinical studies in large or small animals to support registration of Zoetis products when needed
Degree in Veterinary Medicine (DVM or equivalent professional title) or equivalent degree in Animal Health related field. Advanced degree is desirable
5 or more years of experience in the Animal Health, Human Health and/or related industries dealing with regulatory issues in particular and related industry matters in general
Experience developing regulatory submissions and interacting with regulatory agencies preferred
Experience planning, coordinating and executing clinical programs/studies for veterinary biologicals and pharmaceuticals preferred
Proficiency in second language preferred (Spanish, Portuguese, Chinese or Japanese)
Knowledge of livestock and companion animal diseases, treatment and preventative medicine
Knowledge of manufacturing process for veterinary biologicals and pharmaceuticals
Knowledge of veterinary biological and pharmaceutical research and development process
Knowledge of international regulatory requirements for registration and export/import of veterinary biologicals and pharmaceuticals
Knowledge of technical writing
Knowledge of study design, protocol preparation, study planning and execution of clinical studies in large and small animals preferred
Strong verbal and written communication skills and a demonstrated ability to work in a team environment
Proven track record or organization skills

Manager, Regulatory Affairs Operations Resume Examples & Samples

Provide leadership and manage through direct reports the Global Submission Operations (Publishing and formatting) function to ensure the organization consistently delivers high quality regulatory submissions
As a working manager, compile submissions in electronic format as needed
Advise company on optimal submission strategy and evaluate the adequacy of the eCTD format of global regulatory submissions and identify deficiencies requiring further resolution
Work with regional colleagues to drive consistency and efficiency across Global Regulatory Operations regardless of location
Oversee/lead development, implementation and monitoring and ongoing evaluation of departmental processes, standards and practices working in conjunction with other organizations to enhance responsiveness and maximize overall efficiencies
Recruit, manage, train and develop assigned Regulatory Operations staff. Perform mid-year, and annual performance evaluation of direct reports and assist in career development planning
Develop and report publishing metrics to senior management
May participate in management of budgets
Expert knowledge and experience in electronic submissions (eCTD, ICH)
Proven knowledge and experience in Regulatory Operations, including formatting, publishing, submitting, life cycling, and archiving (eCTD) sequences
Working knowledge of eCTDXpress and ISI Toolbox
A minimum of 5 years working in Regulatory Operations including direct experience with electronic submissions
Demonstrated ability to lead, mentor and develop others for future growth and development
Strong analytical, project planning, risk identification and problem solving skills
Excellent written and verbal communication, presentation, and facilitation skills
Ability to provide strategic and operational guidance across all levels of the company and with external vendors
Bachelor’s degree or country equivalent required. Advanced Degree will be an advantage
International experience/exposure preferred

Manager, Regulatory Affairs Resume Examples & Samples

Ensures the overall regulatory strategy aligns with the target product profile (TPP), US specific needs, US bio-similar regulatory environment, and global development strategy for assigned projects
Represents US BRA as a member of the cross functional project team to provide regulatory guidance throughout the research, development, launch and post-approval process. Acts as the single point of contact for the business on US regulatory issues for assigned projects. Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance
Identifies and assesses regulatory risks associated with product development. Defines strategies to mitigate risks
Acts as a FDA liaison contact for project issues. Leads FDA project meetings and major label negotiations with FDA
Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs, including IND, BLA, NDA, 510(k), product line extension application, change control supplements and labeling supplements
Reviews reports from contributing functions and provides comments to assure accurate and complete documents for FDA submissions
Coordinates and supervises the development of regulatory strategies for new medical devices as part of combinational product registration for injectable biologics
Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to bio-similar products and understand the impact on current and future submissions
Leads work plans and provides regulatory affairs direction to lower-level resources. Creates schedules and work plans for monitoring, compiling and submitting filings that are consistent with company standards. Often plays a proactive role in developing and applying new approaches to tracking data and submitting filings
Participates in the modification, development and implementation of company policies and practices for regulatory affairs that affect subordinate resources
Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities. Responsible for implementing operation- al and strategic policies and directives. Develops functional processes for area man- aged
Interfaces with senior management to report on project and program milestones and
10+ years of professional related experience including a minimum of 7 years of regulatory experience preferred. Experience in CMC regulatory and biologics preferred

Manager, Regulatory Affairs Resume Examples & Samples

Subject matter expert for certificate and sample procurement
Primary contact for business projects/initiatives
Primary contact for establishment of new products and brand teams, and related business processes
Participates in development of project plans, timelines and goals
Leads meetings and activities to assure progress
Brings forward metrics to aid in business decisions
Manages, tracks, and maintains oversight of certificate and sample procurement requests; ensures follow up on delayed requests, including direct and indirect reports’ requests
Checks work of others; Responsible for prioritizing requests and other work responsibilities
Oversees accurate record entry and updates in request tracking tools
Tracking/payment/establishment of invoices and purchase orders
Schedules, conducts and documents team meetings as deemed necessary
Communicates and follows up on action items
Analyzes reports and metrics from tracking tools; identifies trends and ramifications
Identifies critical path items; develops mitigation plans for approval by manager
Identifies opportunities for improved business processes and efficiencies
Performs additional business operations tasks as requested
Works with CSCC team and EPD RA Quality Systems and Training and Inspection group (QSTI) and other functional groups to keep department process documentation updated with current national requirements and business processes, including establishment of new processes
Oversees work assignments and results of others
Training of new personnel and in development of department policies/processes
Oversees work assignments of others and/or receives project assignments from manager
Has responsibility for managing projects
Progress on projects reviewed with manager with direction provided on follow-up activities
Participates in and contributes to decisions in cross-functional teams specific to projects
Provides recommendations on project decisions
Contributes content and some analysis for management presentations
5-7 years work experience; preferably in regulatory, pharmaceuticals, R&D or other certificate/sample or records management area
2-3 years regulatory or pharmaceutical experience desirable
Supervisory experience is desirable
High level of understanding of pharmaceutical terms and dosage forms
Basic understanding of regulatory submission procedures is a plus

Manager, Regulatory Affairs Resume Examples & Samples

Researches scientific and regulatory information in order to write, edit, and review submission documents
Compiles and publishes all material required for submissions, license renewals, and annual registrations
Maintains approvals/licenses/authorizations for existing marketing authorizations
Ensures compliant shipment of products through the maintenance of applicable inclusions, spreadsheets, etc
Manage yearly Establishment Registration and Product Listings with FDA and Annual Reporting to Health Canada. Ensures accuracy of US registration and device listing
Adds and maintains information contained in the Global Regulatory Information Database
Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations
Keeps informed of global regulatory information; prepares impact assessments
Represents Alere on US trade associations and contributes to trade positions
Contributes to management review for new or revised regulations and/or other quality system activities
Carries out duties in compliance with established business policies
Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies
Bachelor’s degree (BS/BA) in any biological science. Advanced degree may substitute for work experience (below)
Minimum of eight years of experience in Regulatory Affairs, US and international
Five plus years in an IVD or medical device manufacturing environment
Strong knowledge of federal and international regulations
Strong knowledge of quality systems in a regulated manufacturing environment
Good knowledge of business models, resource planning and budgeting
Possess a high degree of accuracy and attention to detail
Ability to work independently, as well as within a team
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio

Project Manager Regulatory Affairs Resume Examples & Samples

Coordination and execution of regulatory activities related to the Irish Sites
Act as regulatory representative in International projects
Manage coordination of local or global projects as site representative
Closely collaborate with site operations to assure compliance of locally manufactured products to international regulations
Build interface to external bodies, provide submissions and assist in audits
Act as regulatory representative in cross-functional teams
Train and support team members on regulatory activities
Conduct regulatory assessment of design changes and prepare notifications for worldwide submission
Coordinate the creation and maintenance of Technical Documentation
Ensure compliance with regulatory requirements in the life cycle of the products
Coordination and execution of the appropriate regulatory activities to meet the business needs of the organization

Market Manager Regulatory Affairs, Repost Resume Examples & Samples

Attends DOE meetings and webinars to ensure understanding of standards and test procedures
Monitors EPA and participates in stakeholder meetings
Comments on and influences regulations and guidelines with implications to the business
Provides representation with AHRI and ASHRAE related to test procedures
Provide leadership on Emerson engagement with standards committees and impact to business. Important standards in progress are 15 (A2L safety), 34 (new refrigerants) 62 & 62.1 (Ventilation) 55 (Comfort) 189 (efficient buildings)
Works to educate and influence utilities and related industry groups. Provides information and support to ensure Emerson solutions are represented and understood
Provides rational for utility rebates and incentive programs relative to Emerson products
Engages and collaborates with national laboratories and government agencies
Monitors the activities of competitors and customers with these groups

Associate Manager, Regulatory Affairs Resume Examples & Samples

A minimum of eight years of experience within medical device regulatory affairs is required, for the level Assoc. RA Manager level
A Bachelors degree is required. A science degree is strongly preferred
Experience with Class III devices is required; Class III cardiovascular devices preferred
Experience in preparing US original IDE and PMA submissions and CE Mark Design Dossier submissions are required
Must be competent in applying the appropriate regulatory requirements for new products or product changes as it relates to labeling and advertising of III devices. - Requires familiarity with new product development systems
Must possess a strong working knowledge of US /EU regulations that affect Class III devices
Must have strong written and verbal communication skills, and have experience working on cross functional project
Strong ability to problem solve and apply analytical thinking is required

Project Manager Regulatory Affairs Resume Examples & Samples

4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
Principles and requirements of promotion, advertising and labeling
Able to follow scientific arguments identify regulatory scientific data needs and solve regulatory issues

Manager, Regulatory Affairs Resume Examples & Samples

Minimum BS Degree preferably in life sciences, or equivalent work experience. A higher degree (Masters, PhD) and/or RAC certification is preferred, but not essential
The successful candidate will have had a breadth of experience with a minimum of 5 years in a biopharmaceutical company involved in the clinical development of ethical pharmaceutical products. Additional experience in a smaller, biotech company is a plus
Demonstrated experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process. Experience with European/global submissions is a plus
Experience in applying regulatory knowledge to various situations and serve as a source of competitive advantage to the Company
Excellent operational skills including planning, organizing and the ability to deal effectively with a variety of personnel both internally and outside the company
Excellent writing, communication, and interpretive skills
High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently

Manager, Regulatory Affairs Resume Examples & Samples

Work with Global Regulatory Strategy Leader, US Regulatory Strategy Leader and product Regulatory Team to implement plans for identified projects in development
Manage the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. May lead regulatory submission team for projects assigned
Provide input to the regional regulatory development and submission strategies, as assigned
Participate or act as regulatory representative on various cross-functional teams, as assigned
Participate or lead regulatory interactions with FDA, as assigned
Work with Regulatory Operations to prepare FDA submission documents in electronic format
Maintain knowledge on the US competitive landscape, regulatory environment, regulations and guidances
Become knowledgeable with European Regulatory laws/guidances
Provide Regulatory Research and Intelligence support for team as assigned

Manager, Regulatory Affairs CMC Resume Examples & Samples

Minimum BS Degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline. A higher degree (Masters, PhD) is preferred, but not essential. RAC certification or equivalent
The successful candidate will have had a breadth of experience with a minimum of 10 years in a biopharmaceutical company involved with clinical development, manufacturing, testing and distributing ethical pharmaceutical products
Additional experience in a smaller, biotech company is a plus
The successful candidate must also have demonstrated experience with U.S. and international submissions, a working knowledge of FDA/EMA regulations, the regulators, and the approval process
Experience in applying regulatory CMC knowledge to various situations and serve as a source of competitive advantage to the Company. Experienced in all components of regulatory submissions including Chemistry, Manufacturing and Control, non-clinical, and clinical documentation is further required
A strong record of successful U.S. submissions for biologics and drugs which include INDs, NDAs, BLAs, MAAs, Annual Reports, Amendments, Supplements, DMFs. Submission experience in oncology, dermatology, and matrix targeted therapeutics desired

Manager Regulatory Affairs Russia Resume Examples & Samples

Science degree required, higher degree preferred
At least 5 years regulatory experience in international regulatory affairs and/or drug development
Excellent working knowledge of pharmaceutical regulations as they relate to the region of responsibility
Working experience in Russian regulation, relevant knowledge of other European or Custom Union regulation is an advantage
Must be able to work in a fast paced environment with demonstrated ability to deal with competing tasks and demands
Fluent English, both written and Oral

Project Manager Regulatory Affairs Resume Examples & Samples

Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Exercise good and ethical judgment within policy and regulations
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues

Manager, Regulatory Affairs Resume Examples & Samples

Functions as regulatory lead and expert for assigned products and territories
Provides strategic regulatory interpretation of regulations and guidance documents to project teams from early development through post-approval
Oversees creation of and updates to relevant sections of regulatory filings (e.g., IND, CTA, BLA, MAA)
Manages and reviews submission documents to ensure consistency with related filings and regulatory requirements
Interacts with UT product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical), regulatory agencies, contract and partner organizations, as necessary, regarding regulatory issues
Assists with and manages dossier preparation for partner companies in worldwide territories, ensuring accuracy and consistency
Proactively identifies any relevant changes in regulatory landscape that may impact product development or life cycle activities
2 years’ experience leading multinational regulatory projects preferred
Diverse product development experience including oncology, biologics and/or cell therapies preferred
Experience from pre-IND through Phase 3 preferred
Experienced with eCTD structure and lifecycle
Proficient in MS Office and document management systems

Manager, Regulatory Affairs & EHS Resume Examples & Samples

Monitor and stay abreast of global regulatory activity affecting the use of ingredients, product safety, and labeling with particular attention to potential impact on Revlon
Communicate impact of current and emerging requirements and changes within the regulatory environment and work with senior management to modify strategies accordingly
Strengthen the expertise in regulatory processes and procedures to enable the development of actionable regulatory strategies
Ensure compliance for various regulatory-driven activities, including SDS and GHS management, CARB VOCs, Proposition 65 and Green Chemistry initiatives
Provide Regulatory guidance and advice to internal and external stakeholders
Preparation of Regulatory SOPs and guidance documents
Review/Approve product label/artwork for products globally, including harmonization of global warning label requirements
Serve as point person on various industry-related committees as assigned
Perform Building Safety Officer duties, including but not limited to the preparation and training of site safety SOPs and guidelines, building permit compliance, OSHA/DOT/EPA reporting compliance, and employee safety training program
Ensure regional regulatory registrations are properly supported and are of quality and delivered in accordance with agreed upon business timelines
Goal setting and career development of direct reports for continual growth of functional expertise and skills
Bachelor's Degree with a minimum of 5 years of cosmetic regulatory experience required. A Master's degree in regulatory or health-related field is highly preferred
Proven track record of managing high-performing teams with emphasis of meeting deliverables by established deadlines
The ideal candidate should possess the ability to make decisions independently and assess when escalation is appropriate. They must exhibit high attention to detail with excellent written and oral communication, organizational, and problem-solving skills
The ideal candidate must be flexible with the ability to manage multiple projects simultaneously in a fast-paced highly matrixed environment. The individual must exhibit strong team and interpersonal skills
Strong computer experience is highly preferred

Manager, Regulatory Affairs Resume Examples & Samples

Leads work plans and provides regulatory affairs direction to lower-level re-sources
Creates schedules and work plans for monitoring, compiling and submitting filings that are consistent with company standards. Often plays a proactive role in developing and applying new approaches to tracking data and submitting filings
Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities
Responsible for implementing operational and strategic policies and directives. Develops functional processes for area managed
Interfaces with senior management to report on project and program mile-stones and to present project needs
Requires the ability to influence others to achieve results
Assignments are given in the form of objectives with no process defined
May or may not manage lower-level supervisors

Manager Regulatory Affairs & Systems Safety Resume Examples & Samples

Interact with TCS to develop training programs and criteria that are conducive to the GO Operations model
Provide data used to determine manpower requirements
Be the liaison with GO Transit and CN in the screening and hiring of personnel
Ensure that systems are in place to track medical and rule qualification due dates as well as maintaining records of territory familiarization of QCTO’s and CTO’s
Interact with Transport Canada and the RAC on regulatory issues and operational audits
Ensure that regulatory changes and updates are obtained, reviewed and implemented through bulletins/notices and manuals
Conduct risk assessments for proposed changes within BT Operations
Provide support for operational changes that BT needs to implement
Ensure that BT is current on Operating Rules and where required job briefings and/or training
Oversee the BT Health and Safety Committee providing direction for them on day to day and future initiatives
Recommend corrective action for safety incidents and concerns both internally and to the customer and host railroads
Participate in BTNA health and safety conference calls
Ensure that regulatory criteria such as work rest rules, crew training, qualifications, re-certification, and first aid are properly captured for OMS inputting
Be responsible for capturing the relevant H&S information that is inputted into the BT GRACIS data base
Manage the BT Operations Safety Management System (SMS) requirements providing changes and updates to the customer, regulator and host railways
Ensure that any changes are filed yearly with the customer, regulator and host railways
You hold a Secondary School Degree
You cumulate between from (2) to five (5) years of Canadian Rail Operations
You have previous management and regulatory affairs experience
You possess knowledge on the following softwares: Lotus Notes, MS Word, MS Excel, Power Point, Access, Publisher, Crystal and Visio
You own a very strong analytical thinking
You have excellent English communication skills, both written and spoken

Manager Regulatory Affairs Vaccines Resume Examples & Samples

As Manager Regulatory Affairs (RA) - Vaccines you have the responsibility for the preparation and submission of pre- and post-approval documentation for veterinary vaccines in Europe - with a major focus on safety and efficacy section of the dossier incl. detailed and critical summaries
You will participate in international project teams as European Core or Safety & Efficacy Subteam Member for RA and provide regulatory assessment according to current legislation and requirements
One of your various tasks is to develop and realize regulatory strategies for new and authorized veterinary vaccines
Furthermore, you prepare, co-ordinate and respond to a list of questions from the operating units (OPU)/authorities within the project team and assure consistency of the responses
In your position as Manager RA, your duty will also be to liaise with EU competent authorities/R&D vaccine/external experts
Your daily business is to you maintain contact between and within OPUs/ licensees to assist with pre-and post-approval regulatory issues

Manager, Regulatory Affairs MD Resume Examples & Samples

Provide strategic work direction, training and regulatory advice to direct reports and other members of the regulatory department. Interview and hire staff as necessary. Review personnel decisions to ensure harmony with overall department goals
Contribute to the development and implementation of business unit strategic and operating plan
Maintain proficiency on US and global regulatory requirements and develop and maintain rapport with FDA, Notified Body, and other regulatory agencies
Participate in research of regulatory issues and dissemination regulatory information to Production, QA and R&D departments and senior management as required
Lead negotiations with regulatory agencies
Support regulatory authority audits, in conjunction with the QA department
Review labeling for appropriateness and compliance to regulatory requirements and laws
Review changes to existing products and SOPs to define the requirements for regulatory submissions
Provide regulatory affairs training to manufacturing and development teams
Oversee a portion of the department budget; approve spending within defined limits
Develop and implement policies, procedures, and strategies relating to Regulatory Affairs objectives
Provide regulatory training and oversight to internal and external regulatory affairs personnel
Ensure the quality of the product by supporting the development of new and enhancements of existing products and processes
Represent FMSU on the MITA Mammography/X-ray Group and on the MITA technical and regulatory group. This involves keeping abreast of new developments via email, phone meetings and in person meetings, as required
Bachelors Degree and 5+ years experience as a QA or RA professionalwithin a regulated industry
Proven ability to apply regulatory knowledge to solve real world problems in an effective and efficient manner
Significant experience applying cGMP and cGCP to systems and process within a regulated environment
Strong understanding of FDA and EU medical device and privacy regulations
Strong people skills including team management, negotiation and managing without direct authority
Independent self starter, capable of setting, maintaining and achieving goals within a fast paced environment

Technical Manager, Regulatory Affairs Resume Examples & Samples

Provide technical expertise and guidance to Regulatory Affairs in refining and automating business processes in conjunction with system needs
Assesses technical issues with current systems and processes and evaluates systems, and/or upgrades to systems that could meet future business needs for Regulatory Affairs
Gather, analyzes and document user requirements for various business initiatives
Liaises with RA, IT, and other business units as needed, to ensure requirements are appropriately translated into design specifications for systems
Serve as lead for the department on significant matters relating to system and support issues and opportunities, including budget development
Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills and abilities to perform the job
8+ years relevant technical experience and business knowledge, or equivalent combination of education, training, and experience
Experience with RIMS (regulatory information management & systems), including background in evaluating, implementing, validating, document management systems and/or regulatory submission planning & publishing tools
Awareness of IDMP (Identification of Medicinal Products) is highly desirable
In-depth knowledge of regulatory systems and processes, including applicable SOPs/ ICH GxP, current regulatory regulations, ICH specifications, and local regional guidelines
Advanced knowledge of regulatory information management, document management, document & submission publishing xEVMPD/IMPD, etc., concepts and systems, and workflow/process automation concepts and tools
Ability to analyze existing processes and systems, and propose/drive/lead appropriate change that measurably maintains and/or improves quality and efficiency of same
Good business understanding of regulatory and clinical systems
Client-focused approach with strong interpersonal skills
Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices
Ability to independently assess business needs and work with team members
Ability to independently learn new technologies and review/analyze competitive environment
Exceptional organizational skills and effective interpersonal skills
Exceptional analytical ability and problem-solving capabilities
Ability to lead and motivate a cross-functional team
Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
Familiarity with financial, budgeting and reporting tools
Excellent grammatical and exceptional communication skills, both written and oral
Detail-oriented, thorough, and methodical
Ability to create and follow timelines and conduct long-range planning
Ability to multi task and adapt to changes in work duties, responsibilities, and requirements
Ability to communicate information and ideas so that others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interact with others to obtain or relate information to diverse groups
Performs a range of variable tasks as dictated by demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress, and to multi-task

Senior Project Manager, Regulatory Affairs Resume Examples & Samples

Bachelors degree in Healthcare, Engineering or Computer Science- or equivalent education/ experience. Masters preferred
Minimum 6 years in project management required; with combination of education and other experience considered in lieu
Experience working with managers monitoring goals and objectives through high level data analysis and interpretation
Experience working with various stakeholders towards successful development and implementation of projects
Project Management Professional - PMP preferred
Knowledge of project reporting tools for performance monitoring, presentation to executive boards and senior leadership
Proficient in structured querying language (SQL) as demonstrated using SQL Management Studio or MS Access
Knowledge in a quality management methodology, such as lean six sigma, Baldrige, Plan Do Check Act, A3 thinking is required
Advanced Office Suite skills including Outlook, Word, Excel, PowerPoint, SharePoint as well as project management, and similar system to perform analysis, track project progression, develop projections, and submit performance graphics

Manager, Regulatory Affairs, State Licensure Resume Examples & Samples

Conduct research on state standards, legislation, regulations and other policies within the Higher Education industry to assist in the development and implementation of licensure programs, focusing on nursing during the first year
Support the USAHS accreditation/regulatory team as appropriate
Strong understanding of the nursing profession and accreditation issues, especially related to licensure programs in the health sciences

Manager, Regulatory Affairs Resume Examples & Samples

Manage and Oversee preparation for regulator interactions and regulator submissions in a timely manner
Degree qualifications in Commerce, Legal or equivalent business experience
Ability to communicate and engage at a high level with senior stakeholders
Well-developed understanding and skills across risk management principles

Manager, Regulatory Affairs Wealth Resume Examples & Samples

Manage regulatory engagements with and requests from APRA and ASIC
Support the Head of Regulatory Affairs in driving implementation of the Group Regulatory Risk Framework
Provide insight and advice to stakeholders on regulatory risk management to support regulatory compliance, enhance regulator relationships and support sustainable strategic advantage
Manage and oversee preparation for regulator interactions and regulator submissions in a timely manner
Strong understanding of the current regulatory environment and industry standards
Demonstrated background in reporting writing and senior level presentations

Manager Regulatory Affairs Resume Examples & Samples

Provide advice and assessment to support new product and new technology development
Support advocacy and compliance activities across the DuPont N&H portfolio
Interpret and communicate food standards and regulations to internal business partners, including opportunities and risks
MS in life sciences or related field and at least 6 years of experience in food science and technology, nutrition, biochemistry, regulatory affairs in the food industry. Experience working with diverse cultures is a plus
Makes sound commercial decisions based on a thorough understanding of the local business
Understands commercial drivers and is comfortable in finding cost effective solutions
Knowledge of regulatory requirements to gain approval for food ingredients and dietary supplements
General knowledge of scientific methods in R&D and Quality
Honesty in defining gaps and failures, and find solutions to achieve business goals
Demonstrate strong influence on the success of future products and processes
Excellent communication skills in English (verbally, in writing, and in presentations) and competency in working knowledge of another Asian language is a plus
Competency in computer/software tools needed for job

Manager Regulatory Affairs Resume Examples & Samples

Knowledgeable in ICH guidelines, Latin American CMC and core dossier requirement
Ensures timely delivery of high quality regulatory submissions
50% of the time develops global CMC Core Dossier for Module 2.3 and Module 3 CTD sections
50% of the time prepares CMC components of new Marketing Authorization Applications for international countries

Manager, Regulatory Affairs & State Licensure Resume Examples & Samples

Support the other divisions including strategic growth, enrollment advisors, admissions, product development, academic advisors, HR and marketing, by providing technical assistance in state licensure regulations and policy
Collaborate with the SVP, Academic Initiatives and the Legal/Compliance groups to ensure state authorizations and regulatory board approvals for all current and new programs
Collaborate with the accreditation/regulatory team to maintain current approvals and secure approvals for new programs/initiatives
Other duties as assigned, including travel to states as needed
Minimum of 2 years of experience in professional licensure or regulatory/legislative research within the Education industry

Manager, Regulatory Affairs Resume Examples & Samples

Represents Global Regulatory Affairs (GRA) as a member of the cross functional project team and provides regulatory input for the project(s) globally. In this capacity, the GRL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL will work closely with members of the Global Regulatory Team (CMC, operations, regions, labeling), and may ask members of the Global Regulatory Team to participate in cross function project team meetings on an agenda driven basis
The GRTL will ensure development of robust regulatory strategies for the program and will be accountable for developing and maintaining a regulatory strategy document. The regulatory strategy document will evolve over the course of a project’s development, but should include the overall regulatory strategy and how it will deliver on the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory team to ensure that relevant input from all GRA functions is vetted and included in the regulatory strategy
The GRTL is accountable for ensuring that all GRA peer reviews are conducted in a timely manner ahead of key governance meeting and major (issue driven) ad hoc reviews by Sr. Management. The GRTL is also accountable for ensuring that GRA Sr. Management is aware of any major issues with the project, including any changes to risks
The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and Target Product Profile (TPP). The GRTL will also work with the labeling strategist and regions to develop region specific labels
The GRTL, working with the regions, will also interact directly with HAs as needed for the project
The GRTL will work transversally to ensure a properly functional Global
The GRTL will ensure communications from HAs are properly communicated to the business and up through GRA Sr. Management. The communication of any HA feedback should be interpreted and the impact on the project assessed
Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications and/or marketing authorizations
Provide regulatory due diligence assessments of new business opportunities as required
The GRTL will line manage, and/or coach mentor, junior staff supporting the program
Depending on the program assignment, GRTL may also serve as the US Regulatory Lead and responsible for developing and implementing the US regulatory strategy. The US lead will serve as the primary FDA contact as needed and will represent the US regulatory position to senior management governance committees as needed
7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Experience in other relevant functions will be considered. Delivery of at least one major application (NDA/BLA/MAA/JNDA etc…), or extensive experience with late stage development/marketed products. BS in a scientific discipline
Strategic
Extensive knowledge and understanding of complex medical and scientific subject matter as well as evolving FDA policy and guidance related to advertising and promotion topics
Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
Excellent operational skills including planning, organizing and ability to motivate and lead others
Ability to work well within cross-functional teams
Can demonstrate solid oral communication and writing skills
Understanding of the Global and U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
Develops collaborative relationships to facilitate the accomplishment of work goals
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Can build networks to obtain cooperation without relying on authority
Strong sensitivity for a multicultural/multinational environment
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values #LI-GZ

Manager, Regulatory Affairs Resume Examples & Samples

Bachelor’s degree (BS, BA) (technical discipline preferred) with at least 8 years technical experience
Experience working in a broader enterprise/cross division business unit model preferred
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
Ability to maintain regular and predictable attendance
RTT&TE and telecom approval process experience a plus

Project Manager, Regulatory Affairs Resume Examples & Samples

At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development
Excellent communication skills, organization and planning skills and attention to detail
Demonstrated skills and competency in project management tasks and ability to work independently
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively

Group Manager, Regulatory Affairs Resume Examples & Samples

Guide the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responding to questions, and achieving timely regulatory clearance/approval for marketing
Develop Regulatory team expertise in project management, writing, testing methods, and product knowledge, and maintain staffing needs to support all current and near term US filings
Create optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement
Work with Product Development, Clinical Affairs, Quality, Management and other areas of the organization to obtain relevant information and subsequent review of submission content as needed
Review and approve Document Change Orders for US Regulatory, including Regulatory Pathway Form (RPF) determinations for all new and revised products, under departmental guidelines
Review and file Note-to-File documentation with engineering rationales for qualifying changes to 510(k) cleared products or systems and line extensions
Assist in review of product labeling and marketing materials
Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products
Assist in development of relevant regulatory SOPs and training staff as necessary
Ensure conformance to 21 CFR regulations
Attend FDA meetings as requested
Understand relevant surgical techniques and clinical use of implant/instrument systems
Master’s degree in engineering or science-related field, or equivalent
Minimum of 3 years experience in a regulatory capacity within the medical device industry, or equivalent, preferably with orthopaedic or spinal devices
Demonstrated experience in obtaining 510(k) clearance
Demonstrated experience with IDE and PMA approval, preferably including panel-track PMA
Excellent verbal, written and organizational skills
Must be detail-oriented

Manager, Regulatory Affairs Resume Examples & Samples

Strategize and prepare regulatory filings such as IDE, PMA and Design Dossier submissions and subsequent revisions/supplements and amendments
Bachelor’s degree in a related field and 8+ years experience in health-care related industries (hospitals, labs, pharma, IVD or devices), including previous Regulatory Affairs experience and 3 or more years experience in the medical device industry
Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings
Experience in direct communication with regulatory agencies
Experience with international regulatory filings a plus
An advanced degree is desirable. Interventional cardiology experience would be a plus
Excellent written and oral communication skills; technical writing capabilities are a must
A hands-on, decisive, action-oriented style must be evident
Provides solutions which may set precedent
Independently determines method for completion of new projects

Manager, Regulatory Affairs Resume Examples & Samples

Works with Associate Director to implement the regulatory strategy to move our products through development, regulatory approval, and fulfil PMRs
Participates on project teams or sub-teams for the planning of activities needed to meet development program objectives. This includes preparing and managing timelines for all regulatory submissions such as initial INDs, IND amendments, CTx, NDAs, annual reports, meeting requests, briefing books, etc
Assesses and communicates regulatory requirements for submissions and programs to ensure that all development activities are in compliance with applicable regulations and guidelines. This will entail keeping abreast of changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions
Writes Agency correspondence, meeting minutes, and sections of regulatory submissions
Reviews documentation associated with regulatory submissions
Works with the Regulatory Operations to develop submissions in electronic format
Collaborates with the regulatory team and cross-functional teams to promote an environment of knowledge sharing and team effectiveness
At least 5 years of experience in regulatory affairs in the pharmaceutical/biotech industry
Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development
Experience with original IND, BLA or NDA in eCTD formatted submissions
Capable of strategic thinking and proposing innovative solutions to regulatory problems
Demonstrate excellent teamwork and communication skills with ability to impact and influence the decisions of a team
Bachelor's Degree in chemistry, biology or health-related major
Labeling experience
Experience and knowledge of regulatory guidelines x-US

Assistant Manager, Regulatory Affairs Resume Examples & Samples

Responsibilities include working directly on production of regulatory responses and large exams across Regulatory Affairs Unit and collecting and analyzing data in a timely and accurate manner in order to meet internal and regulatory expectations
Under the direction of Regulatory Affairs Counsel or Regulatory Affairs Manager, this position will serve as an expert resource on assigned pieces of larger regulatory inquiries/exams, including gathering, tracking down and researching related information for Managers/Counsel related to specific larger inquiries/exams
This position will interact with GCO colleagues, business partners, advisors, and field leadership across the enterprise related to regulatory inquiries
4 year college degree or equivalent experience
Excellent interpersonal skills; ability to establish strong relationships internally and externally
Energetic, service-oriented individual with a positive attitude
Ability to partner on cases with Regulatory Affairs Managers and Counsel
Strong knowledge of insurance and financial services industry, Broker/Dealer regulatory requirements, Insurance regulatory requirements, compliance policies and procedures
An awareness of Ameriprise Financial products, services and technology/systems as well as supervisory structure preferred

Manager, Regulatory Affairs, Food & Beverages Resume Examples & Samples

Utilizes multiple regulatory databases to ensure the stringent accuracy and compliance of label data for assigned products, including Nutrition Facts, Ingredients, Allergy disclaimers, Dietary/health claims, etc
Collaborates with Regulatory and business team members to verify the usage for all certification symbols, in accordance with SOPs, including Organic, Gluten-free, Non-GMO, Kosher symbols, etc
Partners with Research and Development (R&D) and Quality Assurance to verify net contents statement and slack fill requirements per FPLA and review product and packaging accuracy of consumer safety information, such as (i.e. storage/temperature requirements, choking hazards, expiration dates, etc
Collaborates with Marketing and R&D on New Product Development commercialization process to document and provide input on product benefits for achieving compliance and competitive advantage
Updates and manages all domestic/international technical product information within internal database and provides documentation, as needed
Reviews final packaging artwork to submit to Marketing, Purchasing database managers, and Consumer Relations, as directed
Assists Consumer Response personnel in responding to consumer inquiries
Corresponds with Marketing on package change notification for updating product reformulations
Minimum five years’ experience in a technical function, preferably in regulatory compliance in the food & beverage industry
Advanced knowledge of FDA and USDA regulations, including National Organic Program
Experience with Food GMP’s, SOP’s, HACCP/Food Safety, and Environmental guidelines
Export experience is a plus
Excellent organizational skills, ability to prioritize multiple priorities and strong attention to detail
Computer skills including MS Office programs such as Outlook, Word, Excel PowerPoint
Strong interpersonal skills and ability to communicate (verbal/writing) effectively
Self-motivated and strong analytical / problem solving skills
Ability to collaborate at all levels of the organization and across other functional areas
Ability to maintain a high level of confidentiality
Preferred knowledge of the Consumer Product Goods Industry.EEO/AA/M/F/Veteran/Disabled

Manager Regulatory Affairs Resume Examples & Samples

Support proper and timely registration in all countries as well as ensure that product dossiers are properly prepared, maintained, and accessible
Align activity and effort with the regulatory strategy
Ensure that all registration data are entered into the proper data management systems for covered activities
Under direct supervision of the GRA CC TA Lead, he/she will manage timelines and deliverables for regulatory procedure submissions to Health Authorities
Ensure globally harmonized regulatory CMC compliance for assigned Bayer Products
Be responsible for creation and implementation of appropriate regulatory strategies for worldwide CMC submissions to Health Authorities for assigned products in close cooperation with the respective technical (Operations, QA) and global, regional and local Regulatory Affairs (RA) functions, to ensure timely submission and first cycle approval
Have responsibility for the support of assigned marketed products in close cooperation with country or regional RA with their Health Authorities, and with Pharma Operations, Medical, Clinical, Pharmacovigilance and Marketing so that issues affecting the success the successful maintenance of these products and their life-cycle (variations, renewals or deficiency letter) are addressed appropriately, ensuring regulatory guidelines are met)
Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, BHC Product Supply, Medical, Drug Safety and Marketing, to ensure early identification of major regulatory hurdles and issues with regard to CMC related topics, regulatory guidelines and legal requirements, and coordination of respective corrective actions
Provides active input into GRTs for assigned projects to ensure timely submission and first cycle approval. Responsibility for timely availability and final content of CMC, IND/IMPD, NDA/MAA-, sNDA-, or BLA-submissions for assigned products to Health Authorities, including responses to health authority questions
Responsibility for the CMC change management for assigned development and marketed products, which includes providing regulatory assessments, tracking of CMC changes and processing of requests for related documentation(evaluation, consolidation, prioritization and review), responsibility for coordination of responses to health authority questions, and for implementation of CMC changes after HA approvals with product supply, to ensure regulatory CMC compliance
Ensures adequate surveillance of the CMC-related regulatory environment for assigned products and anticipates and influences changes in this environment globally
Manages scientific support of assigned marketed products with respect to regulatory aspects and Labeling in close cooperation with the respective TA heads
Coordinates and ensures the timely generation of regulatory documents adhering to global, regional and local requirements
Responsibility for the support of assigned marketed products to ensure the successful maintenance of and life-cycle (variations, renewals or deficiency letter), ensuring regulatory guidelines are met
Manages the preparation of registration dossiers related to assigned products and proactively identifies and tracks regulatory activities and /or issues and risks and brings these to the attention of RA CC infrastructure management as necessary
Coordinates the publishing and dispatching activities of the variations to the respective local regulatory affairs as well as submitting through EU gateway. Timely availability and appropriate final content of CMC or LCM-relevant sections of submission dossiers directly influences time to market for products. Non-compliance (CMC) has potential to severely inhibit / stop product sales for individual products and assigned part of BCC portfolio
Ph.D., M.D., or PharmD degree in life sciences with a 2+ years of regulatory experience ; or MS with a 4+ years of Regulatory experience, or a Bachelor’s degree 6+ years’ of regulatory experience
2+ years of regulatory experience in Pharmaceutical Industry

Assistant Manager Regulatory Affairs Resume Examples & Samples

Doctor of Pharmacy (Pharm D)
2 to 3 years of relevant work experience in Regulatory functions in any Pharmaceutical company
Knowledge of Drug Regulatory Authority of Pakistan
Good knowledge of Pharmacy
Must be able to work well with a team
Hard working
Bachelors of Medicine and Bachelors of Surgery (M.B.B.S.) or M.D
Member of Pharmacy Council or PM&DC as applicable
Able to understand complexity of Global and Local Regulatory requirements of labeling
Understanding of DRA requirements for variations including pack design change, source change and shelf life change etc
Ready to accept challenges
Focus on Compliance
To provide assistance in Project Edge; UCB Internalization; Maintenance of Regulatory Data base and OPAL updates. The person will also be responsible for timely completion of Project Edge phase II and remediation submission as per Global guidelines
This position will ultimately contribute in maintaining regulatory compliance in labeling update and timely filing of renewals and/or remediation dossiers
Assisting and compile Product Registration Application’s for timely submission to DRA
Assisting and compile documents/information of any change and addition in formulation, pack size, color, name, indication dosage etc of the registered products with Health Authority
Prepare and compile application for lot release of Vaccines (obtained LRC) from National Control laboratory Ministry of Health to avoid non availability of vaccine
Assistance in compiling of export dossiers and required registration documents for Iran
Responsibility of QMS implementation and perform periodic review of training records

Manager, Regulatory Affairs Resume Examples & Samples

Experience: Bachelor’s degree with 5-7 years of experience
Must have proven ability to manage people and complex programs
Previous experience managing a Unique Device Identifier (UDI) program including in depth understanding of the Regulation and the impact to the Quality System preferred
Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and/or Premarket Approval Applications (PMA’s)
Must possess and demonstrate an excellent understanding of FDA, International ISO Standards, Medical Device Directives (93/42EEC), Canadian Medical Device Regulations (CMDR), Therapeutics Goods Administration (TGA), Pharmaceutical Affairs Law (PAL), and other International Regulation regulatory requirements

Manager Regulatory Affairs Advertising & Promotion Resume Examples & Samples

Manages and executes AdPro materials reviews for compliance with approved product claims and applicable regulations for the Molecular business area, all Lifecycle teams. Main focus US, however, some EU and International compliance reviews may be required
Liaises with authors of AdPro materials and legal to ensure compliant Adpro material to timelines that serve the business needs
Interacts with other business area regulatory staff who are dedicated to LCTs/PTs
Liaises with regulatory compliance staff at the US affiliate
Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical device products (including compliance)
Manages the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings
Monitors and assesses Regulatory developments (e.g. Federal Register publication/notices, FDA guidelines) related to the Company’s products as applicable
Position may have HR responsibility for direct and indirect reports which includes hiring/firing decisions, interviewing, selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints
Serves as primary liaison on AdPro reviews and documentation requests during an audit

Manager, Regulatory Affairs Resume Examples & Samples

BS with 4+ years significant experience in regulatory affairs, or appropriate relevant experience
Requires good scientific background
Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent; Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to product development, preferably vaccines/biological
Exceptional management and organizational skills
M.S; Pharmacy, Chemistry, Biology or Medicine
Effective time management, ability to clearly identify priorities and manage multiple tasks, ability to work in an autonomous manner
.Excellent organizational skills and written/oral communication skills
Working knowledge of electronic tools/systems
Ability to strategize, problem solve, and influence
Experience in providing strategic advice on CMC/clinical advice in cross functional teams
Experience in interacting with external organizations pertaining to regulations of CMC/clinical issues
Knowledge and experience in regulatory requirements from a Global perspective, preferably FDA
Experience in clinical/CMC strongly desirable
Problem solving skills, to be able to cope with this complex, constantly evolving, technical regulatory environment
Frequently deal with multi-cultural responsibilities (managers/scientists of multiple origins)
Ability to coordinate and execute regulatory strategy for a given project/product
Ability to identify and escalate issues and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence

Manager, Regulatory Affairs Resume Examples & Samples

Manages and develops regulatory staff
Prepares and supports regulatory submissions (PMAs, 510(k)s , Design Dossiers, Technical Files, IDE, Notified Body Submissions, revisions/supplements, etc.) in a timely manner, meeting current regulations and guidance document requirements
Participates on project teams representing as regulatory lead to provide inputs and answer questions related to regulatory requirements
Ensures regulatory milestones and timelines for assigned projects are met
Develops regulatory strategies for medical device products to determine regulatory pathways to market
Prepares various presentations to regulatory agency reviewers and/or inspectors as needed
Reviews product labelling to assure compliance with regulatory requirements
Reviews promotional material to assure claims and indications are consistent with approved language/current product classifications
Reviews and approves product complaint and MDR reports and attend MDR/ Vigilance Board meetings
Reviews and approves Document Change Order requests, CAPAs, NCMRs and etc
Interprets and applies FDA and International regulations to business practices and provides regulatory input, advice and guidance to the organization
Monitors, tracks and actively assesses evolving FDA regulations, guidances, points-to-consider, warning letters and policies
Determines applicable registration requirements for medical devices in all countries in which products are to be registered
Manages coordination of international product registrations and licensing documentation
Prepares and/or analyzes marketing approval applications, European Union Technical Files, Design Dossiers, STEDs, Canadian Registrations and other international market registration dossiers for new product submissions, new indications and claims for existing product lines, license renewals, amendments and other associated activities to applicable government agencies
Partners with Clinical to provide input and prepare critical data for physicians and proposals
Develops and manages departmental budgets
At least 5 years of experience in managing Regulatory Affairs or in a healthcare related environment, minimum 3 years of experience with Class III PMA devices
Bachelor’s or Master’s Degree in a related field
Experience working with FDA and International regulations
Experience and involvement with IDEs, PMAs and 510(k) filings
Experience filing submissions in the US and International markets, particularly medical devices
Experience managing functional groups in the development of relevant data to complete regulatory submissions
Superior technical writing capabilities required
Demonstrates excellent communication, decision-making, and presentation skills
Demonstrates critical attention to detail and organizational skills
Ability to build relationships within Regulatory Affairs department as well as other areas of the organization
Ability to oversee day-to-day performance of employees, organize a group and provide leadership
Manages/supervises employees with hands-on and action-oriented style and ability to accomplish objectives
Interventional cardiology experience
RAC (US) certification
Member of RAPS (Regulatory Affairs Professional Society)

Manager Regulatory Affairs Category Resume Examples & Samples

Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug/cosmetic/devices/food and supplements (dependent on category) development and regulatory requirements as appropriate
Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams
Communicates effectively within the function at all levels and within cross-functional Project Teams
May supervise or mentor other team members
Plans, prepares and delivers high quality regulatory files to agreed timelines
May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage
May act as GSK representative to external groups on specific task forces within their field of expertise
Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Project Team
In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc with supply chain and technical excellence
Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions

Manager, Regulatory Affairs Resume Examples & Samples

Lead and mentor a team of regulatory professionals
Develop and deliver innovative regulatory strategies
Collaborate with the global regulatory function to ensure ANZ submission requirements are met
Determine local regulatory risk for submissions and develop risk mitigation strategies
Participate in industry and TGA/Medsafe working groups and committees
Support the commercialization of products through participation in local brand teams
Tertiary qualifications in pharmacy or life sciences as a minimum
A commercial focus and a desire to contribute to the overall success of the business
A team player with an holistic approach to working in a matrix environment
Well organised with a proven ability to meet deadlines and achieve goals
Proven ability to provide innovative solutions to business challenges
Extensive experience in registering new chemical entities and new indications within the ANZ environment
Experience with Class I and II device inclusions desirable but not essential
Cross functional brand team experience

Manager, Regulatory Affairs Resume Examples & Samples

Provide regulatory expertise and guidance for new product development and help develop regulatory strategies for the Americas
Design, plan and manage any GRAS panels required for new products
Work with Sales, Marketing, Operations and Innovation & Commercial Development on ongoing new food ingredients initiatives
Work with Corn Refiners Association and R&D on the obesity issues
Maintain contacts at the Food & Drug Administration
Pursue Food & Drug Administration and other regulatory approvals as necessary for new and existing products
Work with the Group’s legal team on matters, as necessary
Work with Group Public Relations to coordinate the Group’s public positions
Work with international standard setting organizations (JEFCA, Codex, etc.) to make sure specifications are adequate for T&L products
Interface with Heartland Food Products on Sucralose health, safety and regulatory matters
Advise Sales, Marketing, Operations and Innovation & Commercial Development on product labeling, nutritional claims and advertising issues
Advise Quality Control personnel on regulatory matters such as GMP requirements
Provide advice on GMO matters

Manager, Regulatory Affairs Marketed Products Resume Examples & Samples

Preparation and/or coordination of designated regulatory submissions for BioMarin’s marketed products in the EU and Switzerland, in line with corporate objectives. These submissions may include, but are not restricted to, new license applications, renewals, annual reports, labelling updates and variations
Provide contributions to support product development strategy as required
Liaising with BioMarin’s document authoring departments and product specialists
Responsibility for the preparation and maintenance of labelling to support MAAs and other post-licensing activities
Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling for new MAAs or variations affecting the labelling, and in line with required timelines, for products registered in the EU
Liaises directly with BioMarin’s Head office, local Affiliates, distributors or agents to define/clarify submission requirements, and follow up on submissions, requests for supplementary information and approvals with specific country and/or regional responsibility within EU and CH region
Participates in regulatory team meetings and recognized as a knowledgeable resource for Regulatory Affairs in other departments
Makes use of internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies
Participates in routine local process improvements, which have an impact on the working of the Regulatory Affairs function
Manage interactions with EMA or other regulatory authorities under the direction of management
Customarily and regularly exercise discretion and independent judgment in the performance of the duties described above
The candidate is expected to have strong experience in clin-nonclin aspects of Regulatory Affairs in the biotechnology or pharmaceutical industries, preferably with exposure to both development and commercial phases of the product lifecycle
Experience with Orphan Drugs is desirable
The candidate should have proven ability to manage critical projects as part of an interdisciplinary team
The candidate should have experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines
The candidate is expected to have a thorough understanding of relevant drug development regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities

Manager Regulatory Affairs Resume Examples & Samples

Product knowledge and ability to learn new markets such as Cell Therapy, Water Filtration
Compliance with (global) legal requirements by adherence to requirements of existing and new regulations and legislation. Investigate and provide appropriate regulatory intelligence when necessary and ensure compliance
Participates and contributes and provides deliverables to new product project meetings with regards to activities related to product labeling and product registration for on-time product commercialization
Negotiates solutions as they relate to labeling within interdisciplinary departments
Initiated benchmarking meeting with leading pharmaceutical manufacturer to help to eliminate labeling errors
Work directly with in-country representatives to facilitate product commercialization as it pertains to product labeling and registration
Provide guidance and direction pertaining to strategies necessary for product registration
Anticipate and/or identify problems which could potentially delay product registration and provide solutions
RA Reviewer for QARAC, QIRP and LRC processes
Provides technical support and/or RA support to filed sales representative and Pall Medical customers
Works in a manner that supports team work
Completes work to assure commercial, regulatory and customer requirements and is results oriented
Ensures a safe and healthy environment by complying with all company safety policies and procedures
Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws
Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; addressing complaints and resolving problems
Bachelor's of Science Degree with a Major in Biology
7+ years of experience in the medical industry including: Quality Control, Product In-service Training, Product Packaging/Labeling and Regulatory Affairs
Masters Degree or MSc preferred
SAP Master Data experience preferred
Ability to read and comprehend simple instructions, short correspondence and memo’s. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees in the organization
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform the prescribed style and format. Ability to effectively present information to top management, public groups and or boards of directors
Ability to read, analyze and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups and or board of directors

Manager, Regulatory Affairs Resume Examples & Samples

Working with regulatory associates, determine submission and approval requirements
Through regulatory staff provide strategic input and technical guidance on regulatory requirements to development teams
Monitor impact of changing regulations on submission strategies and update internal stakeholders
Maintain annual licenses, registrations, listings and patent information
Review and approve advertising and promotional items to ensure regulatory compliance
Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information
Submit/review change controls to determine the level of change and consequent submission requirements
Provide regulatory input for product recalls and recall communications
Strategize with and advise internal stakeholders on regulatory issues
Prepare and take leadership in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations
Bachelors of Science required, with emphasis on life science or engineering
Advanced regulatory affairs training required – MS, RAC or other professional certification
Minimum of five years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers) with prior experience supervising regulatory affairs professionals
Broad knowledge of materials and manufacturing processes
Must have demonstrated extensive working knowledge with the requirements for medical device registration/licensing in the EU, (Medical Device Directive),Japan, Canada, Australia, Latin America and Asia/Pacific
Solid knowledge in FDA, EU regulations for medical device
Good oral and written communications skills and ability to work on cross-functional teams
Ability to travel approximately 20% of time

Manager Regulatory Affairs, Labeling Resume Examples & Samples

Provide Regulatory support in the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes
Review new labeling for accuracy and for other regulatory requirements such as NDC codes, DEA requirements, Child-resistant text, foreign manufacturer information, etc
Liaise with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, medical, pharmacovigilance) to ensure the accuracy of all information included on the label or in the labeling
Support the review process and coordinate with other Regulatory functions for the submission, approval, and notification of new/revised labeling content
Develop and maintain tools/lists that support the coordination with other functions (e.g., Quality, Manufacturing) to make certain only agency approved labels are produced for appropriate products
Monitor changes to Reference Listed Drug (RLD) products
Support Regulatory Leads by creating labeling documents for FDA submissions
Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies
Complete electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents

Project Manager, Regulatory Affairs Resume Examples & Samples

Provides regulatory direction to development project teams as a core team member, or lead a project team; develops and communicates regulatory strategy for new products
Establishes Zimmer Biomet RA policy and procedures and ensures compliance with them
Keeps all areas of Zimmer informed of regulatory requirements and emerging issues which may affect the registration approval of products
Strong attention to details, and ability to multitask
Understands the overall business environment, the orthopaedic industry and the marketplace
Mastery of relevant Regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products
Able to identify and assess business risks and develop Regulatory strategy
Strong product knowledge
Ability to build relationships with other areas of the organization
Ability to negotiate with Regulatory agencies, management, and other groups as necessary
US Bachelor’s (or non-US equivalent) degree in Life Sciences, Engineering or related field

Manager, Regulatory Affairs, CMC Resume Examples & Samples

Ability to work both independently with minimal direction and within project teams to attain group goals and key project milestones
Demonstrate ability to assess and provide strategic guidance and impact organizational effectiveness including across cross functional teams
Experience in interfacing with relevant global regulatory authorities
Knowledge and understanding of applicable global regulations
Experience and knowledge in biologics and/or proteins

Manager, Regulatory Affairs Resume Examples & Samples

Hands on experience in leading a variety of Regulatory submission activities (ANDAs, 505b2, Post Approval Supplements, PSURs, Annual Reports.)
Experience with and working knowledge of the risk management, REMS and related regulatory process are strongly preferred
Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of a regulatory affairs department
Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate throughout the product life-cycle
Experience in interfacing with health authorities and managing health authority communications
Experience communicating scientific, strategic and tactical information
Familiarity with Trackwise
Ability to manage a variety of assignments
Strong interpersonal skills and ability to deal effectively with a variety of personnel including senior management

Manager, Regulatory Affairs, Japac Resume Examples & Samples

Primary interface to and from the RA personnel in the affiliates
Provides leadership and support to RA personnel in the affiliates. Assesses scientific data for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps
Ensure effective presentation of data, complete and timely responses (including CTAs)
Primary RA interface with Commercial. Represent RA on Area Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product)
Implements Area Regulatory Strategic Tactical Plan for assigned projects for countries in JAPAC region in conjunction with the Global Regulatory Lead and other RA sub‐team colleagues as appropriate
Maintains, monitors and provides input on the regional regulatory environment and policies to understand new regulations, assess implications to the business, develop and execute strategies to respond to the regulations
Represents the JAPAC regulatory function at sub‐teams or client group meetings (i.e. commercial R&D, CMC, etc.) to present regulatory requirements or provide strategic input for the registration of products. Actively supports R&D and affiliate regulatory and clinical operations teams in securing timely approval of registrational clinical trials
Actively participates in training programs and other area regulatory initiatives for JAPAC affiliates
Bachelor of Science degree in pharmacy, pharmacology, biology or related subject
Have in‐depth knowledge of the regulatory requirements of the countries within the JAPAC region
Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful
Strong proven personal development and motivational skills
Proficiency in communicating strategic and tactical issues to management

Manager Regulatory Affairs Resume Examples & Samples

BA/BS, Pharm D, or DVM or MSc in Biology, Life Science or a related field of study; 3-5 years prior Regulatory Affairs experience
Demonstrated knowledge of microbiology, immunology, virology or bacteriology
Experience working on Project teams preferred
Ability to manage multiple priorities efficiently
Requires in depth knowledge and understanding of the North American, European and International regulations/guidelines
Good skills in communication and teamwork

Manager Regulatory Affairs Resume Examples & Samples

Represent the company when communicating and negotiating with FDA or other regulatory authority officials concerning requirements for obtaining approvals of submissions
Communicate current regulatory requirements and provide direction and insight into future requirements to project teams as well as middle and upper management
Maintain a current knowledge of regulatory requirements by continued review of regulations, new guidelines, and trade publications, as well as by participating in the working groups of trade associations such as the Animal Health Institute
Ensure that assigned projects are carried out in full compliance with government regulations
Maintain knowledge and skills in electronic submissions to CVM-FDA
Handle several continuing projects simultaneously
Have a direct impact on regulatory agency decisions as to whether products may be legally marketed and ensure that the regulatory aspects of these projects are completed accurately and in a timely manner
Track the payment of all ADUFA fees to FDA and facilitate
B.S. degree in related science area with 12 plus years relevant experience or M.S. in related science area with 10 plus years relevant experience
Must have thorough knowledge of applicable federal regulations with extensive experience interacting with CVM-FDA, as well as an understanding of FDA procedures and policies
Must be detail oriented with strong organizational, interpersonal, and communication skills
Expert skill level with handling of electronic documents (e.g., Microsoft Word and Adobe Acrobat), presentation software (e.g., PowerPoint), and project timelines (e.g., Microsoft Project), along with an aptitude to learn new systems
Must work well in cross-functional teams that exist in the product development matrix structure in Bayer Animal Health
Sound decision-making capabilities
Must possess good skills in coordinating and influencing outcome to large regulatory projects and working with members of the regulatory
D.V.M. degree with 6 plus years relevant experience or Ph.D. degree in related area with 6 plus years relevant experience

Manager Regulatory Affairs Resume Examples & Samples

Bachelor’s degree in science or engineering related pharmaceutical or medical device field
Masters in Regulatory Affairs strongly preferred
Minimum of 5 years of related experience within a pharmaceutical/medical device company, CRO or similar organization and with minimum of 2 years International/Global regulatory experience in medical device and companion diagnostics development and registration activities

Manager Regulatory Affairs Resume Examples & Samples

Coordinate and review all marketing and import registration applications complied by the business partner to ensure filing timelines and approvals from CDSCO are adhered to
Collaborate with Amgen internal stakeholders such as regional regulatory affairs, CMC, Labelling, Supply Chain, Quality, Medical Affairs and Commercial to support seamless execution of commercial filing and launch plans
Ensure all safety reporting obligations to the regulatory authorities for launched products are fulfilled in a timely and compliant manner
Compile and adapt clinical trial applications per local regulations, ensuring timely submissions, follow-up with and approval from the regulatory authorities
Respond to regulatory queries seeking support and feedback from appropriate functions within Amgen
Ensure regulatory compliance by managing regulatory submissions for notification and/ or approval during the course of the execution of each clinical study including preparation and submission of annual study status reports and study completion reports
Ensure timely registration and maintenance of all approved clinical trials in the Indian clinical trials registry (CTRI)
Import & export license submission, approval and maintenance for clinical trials
Troubleshoot with line management any critical path activities which impact submission with line management
Keep up to date on the implementation of key legislation, regulatory policy and guidance ensuring changes or updates are communicated
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products and understand the impact on current and future submissions
Ensuring that local labeling requirements are developed in alignment with local regulatory requirements and Amgen standards
Ensure maintenance of country-specific details captured in regulatory knowledge center on Amgen GRAAS databases & communicate changes regulatory requirements and their impact to Amgen to key customers and stakeholders
Participate in process improvement initiatives, and recommend process changes where necessary

Project Manager Regulatory Affairs Resume Examples & Samples

Bachelor in Food Science and Technology (or related field)
Bilingual (French and English) written and oral
Minimum of 3 years of experience in Canadian regulatory affairs sector
Experience in research and development, nutrition, or legal affairs
Experience in the agri-food sector, particularly in the areas of product development and commercial communications
Excellent knowledge of Canadian regulations in the food and advertising sectors (dairy and/or bottled water sector is an asset)

Project Manager Regulatory Affairs Resume Examples & Samples

Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate
Competently writes regulatory and/or technical documents with minimal review by senior staff
Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues
Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate
May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
May present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff
May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate
May be involved in a Regulatory and/or Quintiles Initiative
Demonstrates comprehensive regulatory or technical area of expertise
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
Demonstrated skills in chairing small meetings
Ability to work on several projects, retaining quality and timelines and can prioritise workload with minimal supervision
Ability to propose revisions to SOPs or suggest process improvements for consideration
Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years experience* (*or combination of education, training and experience)

Associate Manager Regulatory Affairs Resume Examples & Samples

Providing lead support for RD/RA on Altria Group initiative development, tracking and reporting, including quarterly summaries to Strategy & Business Development (S&BD)
Planning and organizing strategic planning efforts for the RA organization to include game plan development. Track and report RA initiatives
Developing plans, presentations and other materials to support Executive Leadership Team (ELT) game plan, long-term strategic planning, functional planning and all associated reporting
Developing, tracking and reporting measures of effectiveness for RA
Developing and tracking strategies to mitigate assigned enterprise risks and execute ELT reporting
Developing and tracking enterprise measures; developing content and materials for other internal reporting
Managing S&BD project efforts for RA
Bachelor’s degree or equivalent experience in a Science, Engineering, Operations, or Business Discipline
8+ years’ experience in FDA regulated fields and working knowledge of FDA CTP Regulations and Guidance Documents
Strong ability to analyze complex information, distill insights and develop strategic recommendations
Strong leadership and relationship management skills with proven ability to meet goals and timelines
Strong interpersonal/communication skills to interface with management and individuals at all levels of the organization
Ability to negotiate and influence at all levels of the organization
Strong presentation skills to clearly and articulately share project progress and developments
Ability to synthesize disparate and complex data/information to identify implications to strategies

Manager Regulatory Affairs Resume Examples & Samples

Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals)
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areasAMO30037051

Manager, Regulatory Affairs Resume Examples & Samples

Responsible for direct interactions with regulatory authorities on identified projects, and for intercompany communications of regulatory issues and associated risks
Responsible for integration of CMC, clinical and nonclinical development strategies into an overall regulatory product development plan
Supervise direct reports and be responsible for the timely production and submission of regulatory documentation, including INDs and IND amendments and license applications and supplements
Participate in cross-functional subteams representing Regulatory Affairs and foster positive and productive working relationships between project team members and regulatory agency representatives
Prepare departmental guidelines for Regulatory Affairs and communicate new regulatory requirements across the company as appropriate
Participate in the review of external communications including recruitment materials, proposals of abstracts, presentations, and manuscripts, etc
Present regulatory strategies and plans to upper management groups and all company meetings as needed and demonstrate concise and polished presentation skills
Initiate and lead interdepartmental infrastructure projects as required
Demonstrate expertise in and knowledge of specialist technical area(s) as applicable, to be an internal resource for the company
Bachelors Degree in scientific, health care, or related field or equivalent
Strong interpersonal, written and oral communications skills
4-6 years regulatory affairs experience in pharmaceutical, device, or diagnostic industry or in medical/pharmaceuticals field
Demonstrate understanding of regulations and guidelines governing drug development (clinical, nonclinical, CMC and commercial/public relations operations) and an ability to apply this understanding to strategic drug development plans
Ability to work independently according to demanding timelines
Demonstrate leadership and people management skills in team and departmental settings
Excellent organizational, prioritization and planning skills

Manager, Regulatory Affairs Pompe Resume Examples & Samples

Actively contribute to the operational implementation of regulatory strategy for assigned projects
Prepare, coordinate, manage or maintain regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations. This includes ability to coordinate identified regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
Provide review and comment during document preparation, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content
Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions
Coordinate Regulatory Affairs activities with other functional areas as required including representation Regulatory Affairs in cross-functional team meetings
Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.)

Manager, Regulatory Affairs Operations Resume Examples & Samples

Pharmaceuticals
EDM, RIM and electronic publishing software
Disposable Medical Devices
Experience compiling, publishing, validating and submitting in eCTD for various submission types (e.g. IND, NDA, 510(k), etc.)
Experience with eFiling a big plus
Medical Device Software
Document Management Software
"Combination" Medical Device/Pharma/Disposables Products
Class III Medical Device Regulatory Submissions
US Regulatory knowledge for Software Driven Medical Devices
Expertise with Biocompatibility Standards and Regulatory aspects of Material Qualification
Proven ability to manage critical projects such as major regulatory submissions, and regularly meet critical deadlines
Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing
Oversees the development and implementation of systems and procedures used to support regulatory submission (drugs and devices) and publishing activities
Oversees the establishment and maintenance of an archiving/document management system
Oversees a team responsible for producing, tracking and prioritizing FMCNA regulatory submissions and submissions-compliant documents in the electronic format (eCTD and eFiling)
Authors, implements and maintains various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions
Provides training to department and external groups
Evaluates and provides input for new department technologies and collaborates with intra-departmental resources to ensure adherence to infrastructure standards
Compiles, publishes, QC and validates documents for FDA submission
Troubleshoots document issues in MS Word and Adobe Acrobat
Provides advance editing and formatting support
Maintains current knowledge of electronic submission requirements and prepares for future initiatives and requirements
Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce
Interacts with internal departments and external customers; particularly in problem resolution. Acts as an advisor to subordinates to meet schedules and/or resolve technical problems. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations
6 – 8 years’ related experience
Strong computer skills and highly proficient in MS Office applications and Adobe Acrobat (version 5.0 or higher)
Hands on experience with document management systems
Strong knowledge of EDM, RIM and electronic publishing software preferred. Must have experience with electronic submissions, specifically eCTD. Experience with eFiling a plus
Have proven ability to manage critical projects, in particular experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines
Expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines
Outstanding interpersonal and communication (written and verbal) skills
Strong software troubleshooting skills highly desirable
Detail oriented; ability work under deadlines; strong organizational skills required.HARRM

100

Manager, Regulatory Affairs Resume Examples & Samples

Represents the RA function on assigned cross-functional project teams
Interprets and applies regulations by creating regulatory strategies for China markets
Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations
Prepares hardcopy and electronic information packages for submission to regulatory agencies
Reviews validation, clinical and stability protocols and reports for regulatory submission soundness
Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations
Defines, monitors and receives deliverables for submissions
Writes and/or edits submission documents using regulatory templates, or creates new templates
Assembles paper and/or electronic copies for submission
Monitors new and revised regulatory requirements; disseminates information as directed by management
Interacts with regulatory agencies and third party accrediting bodies
Prepares internal procedures for continuous process improvement
Mentors junior members of the department
Provides regulatory guidance and/or training to external departments and partners
Assists with resource planning and budgeting as needed

101

Manager, Regulatory Affairs Resume Examples & Samples

Excellent operational skills including planning, organizing and ability to motivate others
Ability to work independently with minimal direction and to work well within cross-functional teams
Knowledge and understanding of applicable regulations
Experience in interpretation of regulations, guidelines, policy statements

102

Manager, Regulatory Affairs Resume Examples & Samples

Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations. This includes ability to coordinate identified regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
Provide review and comment during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content
Regulatory Affairs activities with other functional areas as required including representation Regulatory Affairs in cross-functional team meetings
Monitor company progress toward fulfillment of regulatory commitments
Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, including the authoring and review of standard operating procedures (SOPs)
Remain current on regulatory requirements (e.g., Domestic and International) supporting the regulatory strategy and clinical operations related activities.)

103

Associate Manager, Regulatory Affairs Resume Examples & Samples

Represents the regulatory function on manufacturing teams and to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and manufacturing issues, and/or reporting to management
Provides guidance for preparation of documentation packages for submission to global regulatory agencies tracking timelines and documenting milestone achievements, ultimately for regulatory submissions, i.e., 510(k)s and various PMA supplements and reports, as well as EU notices of change
Works on multiple projects that span 6 months to 2 years in duration
Researches and disseminates regulatory requirements necessary for strategic and contingency planning
Monitors proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned projects
Reviews product and process changes, and manufacturing documentation to assure regulatory requirements compliance, consistency, and accuracy
Prepares regulatory assessments and documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies. Interacts directly with FDA and other world-wide regulatory bodies regarding submissions and projects
A Bachelor’s degree is required, engineering or scientific discipline (Biology, Microbiology, and Chemistry) is preferred
A minimum of 8 years regulatory affairs experience (6 years regulatory experience with an advanced degree), including experience in preparing domestic and international medical device product submissions preferred. Class II / 510(k)-product experience is preferred
Ability to determine the global regulatory requirements for product and manufacturing changes
Full knowledge of US and global regulations that affect medical devices, Class II (U.S.) and Class IIa devices (EU)
Strong written and verbal communication skills, organizational skills, and aptitude to work on cross-functional project teams, with little or no supervision
Strong problem solving and analytical thinking abilities required
Must have experience handling manufacturing site transfers, contract manufacturers, review of manufacturing and material changes, as well as authoring 510(k)’s, Regulatory change assessments and change notices
Ability to travel 10% of the time (domestic and international)

104

Manager Regulatory Affairs Resume Examples & Samples

Primary responsibilities include managing complaints and inquiries from the Department of Banking and Insurance as well as Division of Medical Assistance and Health
Managing Arbitration Requests
Assisting in preparing Regulatory Reporting around Appeals, Complaints and Grievances
Representing UHC at the State MAAC committee meetings
Chairing the Policy and Procedure Committee for Health Plan
Providing support for preparation of requested material and case files for review of External Auditor
Other projects assigned that support adherence to regulatory or Medicaid contract requirements
Serving as Health Plan coordinator for monitoring and internal reporting of progress on internal and external Corrective Action Plans (CAPs)
Participating in Contract Review Process to determine operational compliance with new / revised contract requirements
Responsible for Health Plans compliance with Data Release Governance (DRG) annual certification process
5+ years of experience working with products that are highly regulated by State and Federal regulations (Medicaid and DSNP)
Experience with researching and understanding provider billing, claim processing, claim edits, authorization process and appeals and grievances process
Strong ability to establish positive relationships across business groups internally and external Regulators
Claim Process or Appeals and Grievances Experience
Regulatory experience with Managed care, and / or compliance expertise
Experience working for a Managed Care Organization or HMO

105

Manager Regulatory Affairs Resume Examples & Samples

Ensures that the expert regulatory advice provided produces results that align with new project development initiatives, acquisition and divestment activities
Leads the development and execution of innovative and integrated regulatory strategies for large scale, complex and/or contentious projects that require approval or oversight by the NEB or provincial regulatory authorities
Leads the preparation of project applications, operations and maintenance notifications, and condition compliance filings. This involves dealing with multi-disciplinary project teams who operate at different levels throughout the organization, including staff, mid-level, senior and executive level leadership
With Law, leads preparation of responses to regulatory issues, information requests and compliance-related matters on behalf of Enbridge before the NEB or provincial regulatory authorities. For example, gathers evidence and inputs from the cross-functional project teams in order to develop recommendations and responses to the regulator
Ensures appropriate regulatory support assigned to project applications and other matters as appropriate
Manages work activities for members of the Regulatory Affairs team in both Calgary and Edmonton which may consist of regulatory specialists, advisors and analysts. This includes coordinating and facilitating the flow of work and advice, establishing objectives, priorities and standards through analysis and problem solving, managing performance, compensation and workforce planning, and performing related administrative functions
Provides oversight, guidance, and support for municipal permitting for Liquids Pipelines and Major Projects
Stays current on regulatory initiatives, emerging trends, best practices and decisions related to regulation of pipelines and corporate emerging platforms throughout Canada
Provides guidance and training to Enbridge staff at all levels of the organization on regulatory matters to maintain and ensure compliance with applicable legislation and regulations
Participates in industry associations, forums, and initiatives related to regulatory matters
Interacts with colleagues in other offices (Canada and US) ensuring appropriate alignment regarding regulatory strategies, advice and processes
Establishes, fosters and strengthens relationships with regulatory authorities. Key point of contact and relationship manager for project-related matters with the NEB, AER and other provincial regulators
Builds relationships with cross functional project team members as well as mid, senior and executive level leadership and fosters collaboration
Professional designation or university degree preferably with specialization in engineering, environment or law
Minimum 10 years directly-related regulatory experience with success in achieving timely project approvals and interacting with regulatory authorities, specifically the NEB and AER
Project Management Professional designation considered an asset
Experience preferably with pipelines or upstream oil and gas operations
Significant experience leading cross-functional teams for successful achievement of team objectives
Demonstrated leadership skills and capacity to develop the skills of his/her team
Excellent written and verbal communication, presentation, and facilitation skills
Share our core values of Integrity, Safety and Respect

106

Manager Regulatory Affairs Resume Examples & Samples

WO degree or higher in Food Technology or equivalent
At least 5 years of relevant working experience
Languages: Dutch, English
Proactive, analytical
Relationship sensitivity skills, team player
Result driven, convincing
No-Nonsense mentality
Pragmatic and integer

107

Manager, Regulatory Affairs Resume Examples & Samples

Responsible for actively contributing to the development and implementation of global regulatory strategy for assigned projects and programs
Responsible for coordinating all aspects of global regulatory submissions relevant to assigned projects or programs, in partnership with regional regulatory colleagues and subject matter experts
Identify and assess regulatory risks for assigned projects or programs
Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial)
Contribute to life-cycle management of products
Prepare and deliver effective presentations for external and internal audiences
Participate in and contribute to preparation of briefing documents and preparation for global Health Authority meetings
Represent regulatory on relevant project teams
Mentor other Regulatory staff members
Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations
Take steps to actively improve interdepartmental communications
Minimum 5+ years pharmaceutical/biotechnology industry experience, 2 years regulatory experience
Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals
Strong interpersonal skills and the ability to deal effectively with cross functional teams, including medical, scientific, and manufacturing personnel
Demonstrated effective cross-cultural awareness and capabilities
Experience in interfacing with relevant regulatory authorities
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Experience in interpretation of regulations, guidelines, policy statements, etc
Sensitivity for a multicultural/multinational environment
Some regulatory International experience preferred
Experience managing submissions
Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project
Good knowledge of GCPs and GLPs

108

Manager, Regulatory Affairs Resume Examples & Samples

Coordinate the compilation, review and submission process for ANDA’s, subsequent amendments, including SPL/PLR (labeling), all interactions and communications with the FDA from product inception to approval, including regulatory support during Pre-Approval Inspections for assigned projects
Coordinate the compilation, review and submission process for Post Approval submissions, including SPL/PLR (labeling), including all interactions and communications with the FDA
Communicate with R&D Formulations, Technical Operations, Analytical R&D, Manufacturing, Quality Control, Quality Assurance and Par’s internal audit group throughout the development and submission process to ensure all submission related documents (batch manufacturing and control records, packaging records and analytical reports) are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently
Communicate and effectively follow-up with the FDA on various regulatory issues
Interact and communicate with Project Management on submission and project time lines
Utilize and remain current with internal/external electronic submission initiatives
Prioritize work flow to maximize efficiency
Interface with internal/external legal counsel and Business Development on patent infringement issues, paragraph IV certifications and notices to patent holders
Insure that the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and USPTO databases are monitored on a regular basis for updated patent and exclusivity information that may affect potential or pending ANDA products
Monitor FDA CDERNEWS and applicable web sites for new Orange Book listings, competitor Paragraph IV Certifications/Approvals and New Guidances, labeling updates that may impact pending/future ANDAs and provide impact on project/company
Conduct regulatory review of innovator products, associated patent and exclusivity status, including pediatric extensions for new product submissions
Conduct regulatory due diligence for internal and/or external R&D projects
Review of company change requests and associated documentation to support change, as assigned
Prepare and/or review of new and revised departmental Standard Operating Procedures
Participate and represent department at project meetings
Represent the company through involvement in professional associations and attendance at various seminars and workshops
Number of exempt employees supervised: 0
Number of non- exempt employees supervised: 0
Bachelor’s degree in a scientific or other related discipline or an equivalent overall level of knowledge based upon previous work experience
5 – 8 years experience in regulatory affairs
Knowledge of government regulations, policies and procedures and current Good Manufacturing Practices
Office required due to confidential nature of work
Limited overnight travel may be required

109

Manager, Regulatory Affairs Resume Examples & Samples

Life Science University degree/Pharmacist/Chemist
Ph.D. highly preferred. MBA, RAC and other degrees/certifications are a plus
5-10 years of experience in the health care industry with exposure to food products, especially dietary supplements, infant formulas and/or medical foods
Exposure to industry groups, government authorities (spec. FDA and Health Canada), and scientific societies
Clear and full expertise in Regulatory Affairs

110

Project Manager, Regulatory Affairs Resume Examples & Samples

Prepare FDA submissions [i.e. 510(k), Pre-Sub, IDE, PMA] including substantial writing of the submission and review documents [i.e. test reports, protocols, labeling], determine and compile appropriate documentation required for the submission and coordinate with various functional team members such as Engineering to obtain the necessary information required for submission
Review Change Orders and determine whether product changes require regulatory actions. In accordance with FDA regulations, generate Letter to File documents or FDA submissions as needed based on the conclusion of the review of the product changes
Perform labeling reviews including product labeling and promotional/advertisement materials
Represent RA department in project meetings and provide regulatory guidance
Generate/update RA responsible quality system procedures as required (i.e. SQP/SOP’s)
Support international and domestic filings/registrations, including generating/updating technical files and design dossiers and other submission documents as needed
Maintain up-to-date knowledge on regulatory requirements, especially FDA and EU requirements
Coordinate with international regulatory team members on product changes and regulatory notification / approval requirements
Provide project team leadership as necessary
Performs other duties or special projects as assigned
Minimum of five years of work experience with a Bachelor’s degree in a medical device Class II/ III environment
Must have working knowledge of regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission
Must be able to provide guidance to functional teams on regulatory requirements
Experience with FDA/GMP requirements for medical device
Experience in Quality Systems per ISO 13485
Ability to work in a Project Team Environment
Computer Proficiency with MS Office (Word/Excel/Access/Outlook)
Excellent prioritizing, organizational, and interpersonal skills
Excellent documentation skills including detail-oriented, record maintenance/ tracking and understanding of document traceability
A detail-oriented individual, with a “can do” attitude, and the ability to work in a team environment, as well as individually (with minimal supervision)
Ability to work in a fast-paced environment, with multiple tasks/projects
Experience in patient monitor systems, hospital-based products, software or electronic device products
Experience with EU harmonized standards
Experience interacting with regulatory bodies, such as the Notified Body

111

Manager Regulatory Affairs Resume Examples & Samples

Interprets and implements the regulations as they apply to Beckman Coulter products, processes and/or procedures to ensure compliance in that geography
Secures and maintains regulatory agency certificates as required for the importation, storage and conditioning of In Vitro Diagnostic reagents and medical devices in that geography
Secures, maintains, and renews product registrations for In Vitro Diagnostic reagents and medical devices as required to market the products in that geography
Communicates with suppliers and other Beckman Coulter regulatory staff to obtain documentation for product registration requirements
Acts as the liaison with regulatory bodies and negotiates resolution of regulatory agency questions
Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes
Prepares the necessary documentation, secures necessary approvals, and executes on product recalls
Ensures procedures for complaint handling and adverse event reporting are followed
Follows-up on adverse events and ensures that the appropriate reports to the regulatory body are completed
Supports the site when a nonconformance exists to ensure appropriate regulatory assessments and requirements are met
Creates and integrates advanced regulatory strategies for global registrations and compliance activities
Provides regulatory leadership in promotional material review, data analysis and product labeling as related to registration and commercialization of medical devices and in-vitro diagnostic products
Collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees to develop harmonized policies, procedures and work instructions for emerging regulatory topics
Supports the process of selection of suppliers and distributors, participates in the processes associated with the purchase of imported reagents and medical devices and provides guidance to third parties to achieve a better understanding of the technical requirements of the company
Monitors the post market surveillance process
Assures that there are no significant interruptions to the business due to regulatory or compliance issues
Manages regulatory affairs staff; makes hiring/firing/disciplinary decisions; communicates job expectations; plans, monitors, and evaluates job results
Experience establishing and implementing regulatory strategy
Experience in writing and submitting regulatory submissions / product registrations to regulatory bodies
Experience in preparing site for regulatory certification and inspection
Experience communicating with the applicable regulatory bodies to their questions and inquiries
Experience with regulatory audits
Strong written and verbal communication skills, works well with diverse groups of people and is able to function independently of direct supervision
Strong problem-solving and organization skills
Demonstrates knowledge of domestic and international regulations and standards

112

Manager, Regulatory Affairs Resume Examples & Samples

Represent Regulatory Affairs on project teams and in management meetings
Communicate and maintain productive constructive relationships with Edwards Lifesciences internal cross-functional teams and external customers as required (e.g. US FDA, Notified Bodies, in-country regulatory representatives, distributors, consultants, etc.)
Review and approve design, development, software/hardware and operations protocols/reports and change orders
Manage and mentor junior members of the Regulatory Affairs team
Monitor proposed and current global regulations and guidance; advise on impact of such regulations and guidance on the company within the scope of assigned project(s)
Requires a minimum of 10 years’ experience in Regulatory Affairs. Medical device experience in other areas may be considered
A Bachelor’s degree is required, preferably in a scientific discipline. An advanced degree in the sciences, Ph.D., or a combination of an MBA or J.D. with a science degree is preferred
Experience in reviewing new and modified products for regulatory impact, determining appropriate global regulatory requirements, and preparing domestic FDA and EU product submissions is required
Demonstrated understanding of basic regulatory requirements for promotional materials. Experience in review and approval of promotional materials is a plus
Requires a strong working knowledge of US/EU regulations that affect Class I, II and III devices; and a good understanding of global regulations
Excellent writing and verbal communication skills; and strong strategic thinking, problem-solving and analytical ability
Ability to influence others at all levels of the organization is essential
Well-versed in program and project management, and new product development best practices
Results oriented, positive “can do” attitude. Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer’s and patient’s needs
A “hands-on” individual who enjoys challenge, is capable and dedicated to getting the job done with minimal direction
Continuously develops the talents of self and others for current and future business needs; motivates self and others to achieve high performance
Well-organized and accustomed to maintaining excellent records
Requires the ability to travel 10% of the time (domestic and/or Europe)

113

Manager, Regulatory Affairs Resume Examples & Samples

Excellent telephone and written communication skills with proven prior experience
Proficient with computer programs desirable
Five (5) years previous work experience (to include some laboratory work) in the pharmaceutical industry, preferably in area of drug regulatory affairs, documentation, compliance, etc

114

Associate Manager, Regulatory Affairs Resume Examples & Samples

Prepare and provide guidance to colleagues for preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans
Maintain departmental and source company databases of regulatory approvals
Complete copy and labeling review as required
Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Singapore and request the documentation required for registration submissions
Build constructive relationships with the local health authority by compiling and creating internal guidelines on submitting high quality submissions and providing prompt responses to questions
Maintain an awareness of new legislation, policies and guidelines impacting Johnson and Johnson medical products for the Singapore market
Contribute to continuous review and improvement of processes within the Singapore Regulatory Affairs (RA) department to ensure consistent, efficient and effective practices across the team
Contribute to RA Team meetings to learn from colleagues, share experiences and best practice
Assist Manager and RA colleagues in supporting other product portfolios or RA activities, as required
Take lead responsibility for coordinating the release for supply of unapproved medical devices under the Special Access Scheme (SAS)
Establish meetings with marketing colleagues to share information about new products, line extensions and changes to currently approved products and review timelines for product approvals

115

Manager Regulatory Affairs Resume Examples & Samples

Plans own work assignments; may plan and/or delegate work to others
Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company. Compiles materials required in submissions, license renewals and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical and development protocols
Determines data requirements and risks for earliest possible approvals of regulatory applications
Oversees the collection of documents, records, reports and data from Development, Clinical Affairs, Quality and Operations Departments for inclusion in regulatory documents
Manages submissions for FDA product approval including 510(k)s, PMAs, INDs, BLAs as assigned
Prepares international registration dossiers for use in international registration by Roche Diagnostic Affiliates
Works on diverse problems requiring significant analysis and evaluation of intangible variables; may refer to established precedents and policies
May represent Regulatory Affairs on project teams and is responsible for monitoring the activities associated with the project plan
Representative on Corporate Export Control Board and responsible for designated export activities including export license applications

116

Manager Regulatory Affairs Resume Examples & Samples

Developing and executing regulatory strategies for assigned projects while focusing on the main markets, US, CAN and South America. This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation
The incumbent will be responsible for supporting the US submission and monitoring submission timelines and timely responses to requests by competent authorities. It also includes constant development/ improvement of product development and RA processes
Support international product registration by consulting the responsible RA Manager for international projects
Monitoring of legislative environment in main markets, i.e. US and define and maintain an overview of the regulatory requirements and changes in the areas if applicable
Accountable for product related labelling and marketing material
Training internally on relevant procedures and requirements
Willing to travel globally, including outside normal working hours. (appr. 10%)
To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures
Bachelor’s degree in a Life Sciences discipline
Minimum 5 years’ experience in RA with knowledge of ISO 13485 and cGMP
At least 5 years of experience with strong knowledge of quality system requirements specifically FDA’s 21 CFR Part 820
1+ years of experience in preparation for and participation in and FDA inspections
Masters Degree or MSc in a Life Sciences discipline preferred

117

Manager Regulatory Affairs Vaccines Resume Examples & Samples

As Manager Regulatory Affairs (RA) - Vaccines you have the responsibility for the preparation and submission of pre- and post-approval documentation for veterinary vaccines in Europe - with a major focus on safety and efficacy section of the dossier, incl. detailed and critical summaries
You will participate in international project teams as European core- or Safety & Efficacy subteam member for RA and provide regulatory assessment according to current legislation and requirements
Furthermore, you prepare, co-ordinate and respond to questions from authorities/affiliates and assure consistency of the responses
In your position as Manager RA, your duty will also be to liaise with EU competent authorities and R&D vaccine/external experts
You maintain contact between and within affiliates/licensees to assist with pre-and post-approval regulatory issues

118

Manager, Regulatory Affairs, CMC Resume Examples & Samples

30%
Minimum of 3 - 5 years of related experience within a pharmaceutical company (or equivalent via RAC or other regulatory), CRO or similar organization and with minimum of 2 years International/Global/US CMC regulatory experience in biologics, recombinant and/or small molecule regulatory activities
Knowledgeable in FDA and ICH guidelines relevant to CMC aspects of product development and maintenance
Experience in directing interactions with regulatory authorities desirable
Ability to manage complex projects, timelines and teams in a matrix team environment. Excellent analytical and communication skills – both verbal and written. Ability to communicate effectively to multiple levels of the organization with strong negotiation skills

119

Associate Manager Regulatory Affairs Resume Examples & Samples

Experience in the Pharmaceutical Industry
Experience in a Quality Assurance and quality systems environment
Knowledge of local regulatory requirements and of local drug regulations, relevant sections of the EU regulations and directives and ICH guidelines
Additional experience with European Regulatory Affairs and EMA/Centralised Procedures is an advantage
Detail-oriented, excellent priority setting and strong analytical and diagnostic skill
Ability to anticipate problems, be able to suggest solutions and implement appropriate procedures
Excellent interpersonal skills, can work independently as well as contribute to the team
Communication skills (written and oral)
Strong identification with Celgene’s values
Fluent in English and one or more of the Scandinavian languages
MONEU

120

Project Manager Regulatory Affairs Resume Examples & Samples

Supports or leads work streams (such as Legal Manufacturer Alignment and China Specific Package Inserts) related to the China Acceleration Project for Alinity i and c within International Regulatory Affairs
Coordinates regulatory activities within the scope of the China Acceleration Project
Supports regulatory activities related to the China Acceleration Project and assists in creation and maintenance of IPMF and regulatory documentation such as China specific regulatory certificates, testing documentation and related certificates
Supports preparation of China submissions and notifications
Leads activities related to China Specific Package Inserts,

121

Project Manager, Regulatory Affairs Resume Examples & Samples

Coordinating the planning, preparation and submission of global regulatory CMC-related submissions, including Marketing Application(s) and post approval changes
Ensuring that all submissions are complete, accurate and meet relevant requirements, and that they are prioritized & filed so that there is no regulatory impact on supply
Management of CMC submissions and follow up with Health Canada until final Health Canada regulatory decision. This includes interacting with Health Canada and being a primary contact with Health Canada with regards to the submissions
Interfacing with global Regulatory partners and internal cross functional teams
HC requests (e.g., requests for information) are assessed, communicated to management & Global & managed as a priority & within required timelines
Filing and maintenance of CTA submissions (CMC) with Health Canada and compliance with local and global SOPs
University Degree, B.Sc. or higher in Chemistry or Health Sciences or equivalent, plus at least 2 years of experience in regulatory affairs or a related function in a pharmaceutical and or biotechnology company
Working Knowledge of Health Canada regulations, guidance and policies, including a high level understanding of the Health Canada regulatory requirements for CMC submissions
Experience with biologics is an asset
Excellent time management skills and the ability to work independently with minimal supervision
Outstanding interpersonal and communication (written and verbal) skills
Proficient with computer and standard software programs, with excellent word processing, presentation and spreadsheet application skills and the ability to learn new computer interface systems
Detail oriented, with a high level of accuracy and quality in work
Language: Bilingual (French and English)

122

Manager, Regulatory Affairs Resume Examples & Samples

3) Ability to manage complex projects and timelines in a matrix team environment
4) Strong oral and written communication and presentation skills
5) Demonstrated interpersonal skills including strong negotiation skills
6) Ability to independently identify compliance risks and escalate when necessary
7) Ability to coach others
8) Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects
9) Higher degree/PhD will be an advantage

123

Associate Manager Regulatory Affairs Resume Examples & Samples

Line Management of the Regulatory staff in FLEX team, including hiring, performance management and development
Resource Management & Training
At least 5 years professional experience within Regulatory
Proven people management experience
Bachelor or higher graduate degree in science-related field
Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial Authorisations Expert knowledge of ICH and other global regulatory guidelines
Excellent English language skills
Good organizational and planning skills
Ability to motivate and integrate teams and teach/mentor team members

124

Manager, Regulatory Affairs Resume Examples & Samples

Participates on project teams or sub-teams for the planning of activities needed to meet development program objectives. This includes preparing and managing timelines for all regulatory submissions such as initial INDs, IND amendments, CTx, NDAs, meeting requests, briefing books, etc
Assists in the development of an tracking documents to ensure all INDs related to a given compound are up-to-date
Assesses regulatory requirements for submissions and programs to ensure that all development activities are in compliance with applicable regulations and guidelines. This will entail keeping abreast of changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions
Performs regulatory research to determine approval precedents, clinical development pathways, competitor program development
Performs literature searches to supplement knowledge of various indications
At least 3 years of experience in the pharmaceutical/biotech industry
Knowledge of regulations and guidelines related to drug development

125

Manager, Regulatory Affairs Resume Examples & Samples

Assist with researching regulatory requirements applicable to School of Nursing programs
Monitor current and proposed regulatory changes that may affect School of Nursing programs
Provide support to the School of Nursing in understanding and complying with relevant regulatory and accreditation requirements
Provide support to the School of Nursing with developing strategies and procedures for obtaining and maintaining relevant regulatory and accreditations requirements
Perform quality assurance to ensure that regulatory requirements are appropriately operationalized
Develop clear, concise research reports and, when appropriate, communicate research findings to related groups
Maintain ongoing research on regulatory requirements, standards and accreditation
Provide support to College and program leadership with the oversight of international offerings for all School of Nursing programs including practicum and field experience requirements and policies
Assist the School of Nursing with the preparation of proposals, submission of documents (e.g., state authorizations), and development of responses to regulatory and accreditation bodies as needed

126

Project Manager Regulatory Affairs Resume Examples & Samples

Responsible for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents
Responsible for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs
Provide regulatory input to product lifecycle planning and in all stages of product development. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions. Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
Interpret and apply regulatory requirements. Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.)
Recruit, develop and mentor regulatory professionals. Maintain regulatory data in electronic systems
Depending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (regulatory responsibilities for clinical trials; regulatory submissions; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings and patent information; review and approval of label changes, advertising and promotional items; oversight of systems related to product safety issues and product recalls, project management etc.)
Provide leadership without direct authority (i.e., project leader) and provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments
May mentor other department members
Develop, communicate, and build consensus for operating goals that are in alignment with the division
Provide leadership by communicating and providing guidance towards achieving department objectives
Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. Perform work without appreciable direction
Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc
GxPs (GMPs, GLPs, GCPs)
Communication skills and ability to
Work with and negotiate with people from various disciplines, organizations, and cultures
Follow scientific arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy
Evaluate various technical alternatives and perform risk assessment and analysis
Create and manage project plans and timelines
Manage multiple and competing priorities
Think analytically; creatively solve problems; organize and track complex information
Plan and conduct effective meetings
Proficient computer skills
Execute and manage technical and scientific regulatory activities
Function independently as a decision-maker on regulatory issues and assure that deadlines are met
Effectively communicate, prepare, and negotiate internally and externally with key stakeholders, various regulatory agencies, trade associations, etc
Create immediate to long-range plans to carry out objectives established by top management

127

Manager, Regulatory Affairs Resume Examples & Samples

Proficient use of Microsoft Office, Word, Excel, PowerPoint, Visio
Project oriented requiring minimal supervision
Must be detail-oriented, proactive and adaptable
Excellent organizational, teamwork, and collaboration skills
Demonstrated ability to acknowledge issues or problems and work quickly to identify solutions
Previous experience, reviewing and evaluating scientific information and developing regulatory strategies for device and/or drug, biologic products
Must possess and demonstrate an excellent understanding of domestic and international regulations for key countries and other markets as required
Must have experience interfacing with regulatory agencies, possess excellent verbal, technical, written, project management and communication skills

128

Manager Regulatory Affairs Resume Examples & Samples

Provide leadership and regulatory insights to the cereal, meals and drinks business
Partner cross functionally with Marketing and Product development to proactively identify and create opportunities for innovative product claims and positioning
Ensure that products are in compliance with local regulations with respect to product labeling and design
Ensure that all nutrition and recipe product claims and marketing materials are in compliance with local regulations and are appropriately substantiated and documented
Ensure compliance of product ingredients, food additives, nutrition information, and claims
Provide regulatory interpretation and guidance to Project Teams; specifically to product design, food ingredient approvals and marketing for appropriate product claims and advertising
Identify, assess and clearly communicate to the Director Regulatory Affairs any potential regulatory risks as well as recommended actions
Review all label artwork, consumer communications, website copy and other communications for regulatory compliance and technical accuracy
Advise on product variances and compliance criteria
5 + years of experience with regulatory compliance or regulatory affairs management
Strong project management, technical and communication skills
Proactive, accountable and forward thinking

129

Manager Regulatory Affairs Resume Examples & Samples

Prepare Scientific Advice Packages / Meeting with authorities, PIP submissions, ODD submission and/or coordinate MAA submissions
Project management oversight of a European or Global regulatory team
Effective interaction and meetings with Regulatory Agencies and Clients
Project-level responsibility to stay within budget, complete work on-time and quality deliverables for projects
Provide strategic insights to support the European team
Have significant experience working in the service sector of Regulatory Affairs (6+ years) in particular
You should have hands on experience of all or some of the following areas
Excellent communication and organisation skills

130

Project Manager Regulatory Affairs Resume Examples & Samples

Lead the planning and implementation of strategic regulatory projects, focusing on Integration, Regulatory Compliance and Regulatory Efficiencies
Facilitate the definition of project scope, goals, objectives and deliverables with management, supporting business strategies
Define project tasks and resource requirements, working with management to identify key contributors and skill sets
Schedules, leads, and documents meeting minutes and action items of project core team meetings
Manage project budget, identifying required travel, contract resources, licenses, fees associated with the project and timing of accruing these expenses
Plan and schedule project timelines, track project deliverables using appropriate tools and methods
Provide direction and support to project team and encouraging team work and a positive atmosphere
Ensure all activities are performed meeting current quality standards and regulations
Constantly monitor and report on progress of the project to all stakeholders, identifying risks and steps for mitigation. Escalate issues or delays as appropriate
Implement and manage project changes to achieve project outputs within required timelines
Lead project evaluations and assessment of results; identify lessons learned once the project is completer
Attention to detail and accuracy, excellent organizational and planning skills
Bachelors Engineering or related field
5+ years of medical device experience
3+ years of regulatory affairs experience
Prior project management experience desired

131

Manager Regulatory Affairs Established Products Resume Examples & Samples

Support the regulatory strategy for assigned established products without active life cycle management in close cooperation with respective therapeutic area heads, country or regional RA with the Health Authorities, and with Pharma Operations, Medical, Drug Safety and Marketing
Represent Regulatory Affairs on assigned Project Teams and/or Brand Teams associated with established product maintenance and development
Ensure adherence to regulatory guidelines and compliance requirements for Marketed Products
Ensure adequate surveillance of the regulatory environment related to assigned Marketed Products and influences and anticipates changes in this environment
Achieve assigned regulatory affairs project objectives
Maintain the Regulatory Core documentation for established products
Maintain all regulatory documents needed to support Maintenance of Marketing Authorizations (New Product Development (NDAs), Investigational New Drugs (INDs), etc) for assigned projects in line with current quality requirements, guidelines and priorities
Complete regulatory input into annual safety submissions Periodic Benefit-Risk Evaluation Report (PBRER) and New Drug Applications (NDA) annual reports
Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life sciences with two (2) years direct experience pharmaceutical industry experience/or equivalent experience gained at the end of an industry Fellowship, M.S. with four (4) years of experience in biomedical activities, or B.S. with six (6) yearsof experience in biomedical activities
Basic knowledge of local Health Authority (HA) regulations (FDA or European Medicines Agency (EMA)) to support filings
Scientific and technical expertise, including the ability to develop robust regulatory timelines and action plans covering technical and labeling variations as well as line extensions
Knowledge of drug regulations and guidance documents on variations/drug development in all main countries
Analytical regulatory skills
Demonstrate originality in problem solving as applied to drug Regulatory issues
Focus and target oriented in a complex scientific / technical environment
Must be able to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure
Must be able to harmonize and reconcile competing objectives to achieve the overall objectives
Ability to work in English
Thorough knowledge of company policies and procedures in drug development and maintenance
Experience dealing with Drug Regulatory Bodies
Ability to work in German

132

Associate Manager, Regulatory Affairs Resume Examples & Samples

Comply with Celgene Policies, SOPs, WPs, Guidance Documents & Work Instructions
Understand Canadian regulatory precedents for projects
Lead local regulatory submission team
Implementing Canadian regulatory strategies as assigned
Manage project timelines & regulatory deliverables, communicating status to the Regional Regulatory Strategy Leader in the US and local Canadian management as assigned
Preparation, compile and assemble submission documents, e.g. Content plan, Product Monograph, briefing documents, scientific advice and regulatory responses, in collaboration with Canadian regulatory management
Perform QA checks on submission documents to ensure quality of the content & compliance with regulatory guidelines
Ensure that copies of regulatory documents, including submissions, contact reports & correspondence with regulatory agencies are archived
Participate on commercial or product launch teams as a Core Team Member
Perform advertising and promotional review of materials related to assigned projects under the supervision of Canadian regulatory management
Schedule pharmacy audits, request pharmacy metrics, perform audit, prepare and gain approval for final audit assessment
Participate in pharmacy audit calibration assessment, year-end audit report and assessment of effectiveness and planning meetings
Bachelor’s degree in a clinical discipline (e.g., BSc. Phm, RN, MD)
At least 2 years’ regulatory experience in any combination of brand name pharmaceutical industry, Health Canada, HTA assessment, private insurance, provincial funding agency or health discipline regulator
Previous clinical experience in a direct patient care setting or clinical trial monitoring in Canada or the USA
Previous experience in design, implementation or monitoring of a Risk Management Plan desirable
Demonstrated strong accountability skills
Ability to review & critique data originating in other functional groups
Strong analytical skills, i.e. able to research topics & extrapolate critical information
Good understanding of drug development & clinical trials
Understand the product lifecycle
In depth knowledge of Health Canada requirements
Keen understanding of the patient-healthcare professional interface

133

Manager, Regulatory Affairs Europe, Oncology Resume Examples & Samples

Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of post-approval submissions in the EEA, Switzerland and non-EU CES countries
Handle new product registrations in collaboration with the Regulatory Affairs Director, EU for the assigned products
Manage submissions and interactions with the EU regulatory agencies
Liaise directly with Headquarters and US-based cross-functional teams to communicate regional requirements and ensure compliance with all the required regulations for assigned projects
Manage centralized procedures, working in conjunction with regional subsidiary staff for decentralized procedures and provide critical assistance for national submissions in the above-mentioned region
Work with project teams to develop and implement regulatory strategies (including scientific advices and paediatric investigational plans, or orphan designation), identify regulatory risks, and enable earliest possible approval
Ensure regulatory strategies are aligned with project teams and business objectives and deliverables
Ensures regulatory milestones for assigned projects are met
Maintenance of a sound scientific knowledge and expertise for all assigned product areas
Stay abreast on changes in the EU environment which could affect the MSD regulatory strategy
Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams
Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives
Develop and implement effective processes to meet business objectives and ensure appropriate compliance with regulatory requirements
Minimum 2 years of experience in the pharmaceutical industry, preferably within Regulatory Affairs
Ability to manage multiple projects with changing priorities
Ability to work in cross-functional and international environment
Detail- and goal-oriented, quality conscientious, and customer focused
Knowledge of EU regulations, guidelines and regulatory processes for product life cycle maintenance
Ability to adhere to strict project timelines, strong team player
Problem solving skills, with ability to identify,analyze, and resolve problems in a timely manner

134

Manager Regulatory Affairs Resume Examples & Samples

Direct management of regulatory affairs personnel, consultants, and projects by setting performance standards, performing annual reviews, and overseeing project management, progress, and timely completion
Prepare and provide guidance for other employees related to Regulatory Strategy
Review and approve all design control documentation, global submissions, engineering change requests for design, manufacturing, and labeling changes, customs requests, and deviations to ensure compliance with FDA and international government regulations
Represent the company with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities
Work with in-country personell/consultants to manage global submissions
Maintain departmental performance metrics
Project and budget management
Ensure that internal training programs, policies and procedures are implemented and continuely evaluated and updated to maintain compliance with current regulatory and industry standards
Ability to prioritize, multi-task and adapt to changes
Ability to work within budget constraints
Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents
Ability to write, review, and provide training on detailed technical regulatory submissions, reports, and business correspondence
Ability to effectively present information to other employees, management, and regulatory agencies
Computer skills, including Microsoft Office Suite and Microsoft Outlook
Bachelors degree in engineering, life sciences or equivalent technical field
5-10 years experience in the regulatory field or regulated industry
Experience with medical devices, orthopedics preferred
Extensive knowledge of FDA and applicable international regulations and standards required
Experience with planning and preparing complex regulatory submissions for global filings to include, but not limited to the US (i.e., PMA, IDE, 510(k)) Europe and Japan
Professional certification desireable

135

Manager, Regulatory Affairs Resume Examples & Samples

Combined 5+ years experience with increasing levels of responsibility performing regulatory submissions and compliance assurance in chemical and/or medical device companies. Significant experience managing legal and/or government compliance matters or support to product registration projects may be substituted for industry experience for highly qualified individuals
Additional experience in auditing, quality control or quality assurance in chemical and/or medical device companies is highly desirable
Excellent working knowledge of one or more of the following regulatory specializations: (1) US FDA device and/or drug product approval processes, (2) US FDA device and/or drug QSR & cGMP regulations, (3) US EPA regulatory requirements, (4) EU medical device, biocides, chemicals and cosmetics marketing requirements and/or (5) Canadian device and drug approval and compliance requirements
Excellent problem-solving skills
Demonstrated experience working on and leading cross-functional teams
Demonstrated excellent organizational, oral and written communications skills
Must have excellent PC skills including Microsoft Office applications
This position has direct supervisory responsibility for professional staff. In addition, the Manager Regulatory Affairs will lead teams including other regulatory staff and staff from other disciplines in achieving the objectives of assigned projects

136

Manager Regulatory Affairs Resume Examples & Samples

Execute and manage technical and scientific regulatory activities
Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met
Effectively communicate, prepare and negotiate both internally and externally with various regulatory agencies
Properly interpret and apply regulatory requirements
Interfaces with a variety of management levels on significant matters, often requiring the coordination activity across organizational units
May lead a cross-functional or cross-divisional project team
Provides technical leadership to business units
Minimum 7 years’ relevant experience in a regulated industry
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
GxPs (GCPs, GLPs, GMPs)
Principles and requirements of promotion, advertising and labelling
Domestic and international regulatory guidelines, policies and regulations (including Europe)
Ethical guidelines of the regulatory profession, clinical research and regulatory process
Drive gap analysis for new regulations

137

Manager, Regulatory Affairs Global CMC Resume Examples & Samples

Coordinating planning, writing and reviewing Module 2 and 3 sections of all regulatory submissions (Annual Reports, Renewals, Variations, Supplements, Notifications and YPBRs)
Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies (through application of professional/technical expertise and team procedures) for commercial products under the supervision of GRA-CMC leadership
Support EU, US and global commercial license maintenance
Coordinate the preparation and timely submission of responses to regulatory agencies, under the supervision of GRA-CMC Leadership. Manage timelines to ensure approvals are timely and development objectives are met
Act as regulatory CMC representative at internal meetings for CMC related issues
Maintenance of current regulatory product information to support product release for assigned commercial products
Support GRA-CMC team projects for module 3 writing or health authority responses, as required
Support continuous improvement opportunities for the GRA-CMC and the broader GRA team
Must have experience with CMC regulatory documents (variations, supplements etc.)
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
BSc/BA with a minimum of three years of regulatory CMC experience
English language - written and verbal communication skills

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