Manager Regulatory Affairs Resume Samples

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JH
J Hilll
Jewel
Hilll
930 Karen Bypass
Detroit
MI
+1 (555) 473 9182
930 Karen Bypass
Detroit
MI
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
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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15 Manager Regulatory Affairs resume templates

1

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
2

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
3

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
4

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
5

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
6

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
7

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
8

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
9

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
10

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
11

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
12

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
13

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
14

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
15

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
16

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
17

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
18

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
19

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.)
20

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
21

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)
22

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
23

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
24

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
25

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
26

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)
27

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
28

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
29

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
30

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
31

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
32

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
33

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
34

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
35

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
36

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
37

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
38

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
39

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
40

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
41

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
42

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
43

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
44

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
45

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
46

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
47

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
48

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
49

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
50

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
51

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
52

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
53

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
54

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
55

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
56

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
57

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
58

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
59

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
60

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
61

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
62

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
63

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
64

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
65

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
66

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
67

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
68

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
69

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
70

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
71

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
72

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
73

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
74

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
75

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
76

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