Senior Manager, Regulatory Affairs Resume Samples

4.6 (101 votes) for Senior Manager, Regulatory Affairs Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the senior manager, regulatory affairs job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

Resume Builder
CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.
USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.
SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

Create a Resume in Minutes
MS
M Stark
Moshe
Stark
416 Witting Land
Houston
TX
+1 (555) 642 5608
416 Witting Land
Houston
TX
Phone
p +1 (555) 642 5608
Experience Experience
Chicago, IL
Senior Manager Regulatory Affairs
Chicago, IL
Botsford-Weber
Chicago, IL
Senior Manager Regulatory Affairs
  • Ensuring that checking and auditing procedures are carried out
  • Manage interactions with FDA on CMC issues
  • Assist in the review and policies and procedures
  • Ensuring that the new product registration is performed on time before the launch
  • Develop and recommend regulatory strategies
  • Serve as Regulatory Affairs representative on facility/site Local Change Management Boards
  • Collaborate with Device Regulatory International personnel who perform EU based (legal manufacturer) registrations
New York, NY
Senior Manager, Regulatory Affairs
New York, NY
Ortiz LLC
New York, NY
Senior Manager, Regulatory Affairs
  • Develops content of regulatory documents working with other functions as necessary & contributes to review of documents before submission
  • Manages departmental spending to the established budget
  • Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement
  • Develop a product regulatory timeline aligned to the company’s product development, with key regulatory milestones, and activities for agency filing
  • Support process improvement initiatives, standards development, and metrics
  • Assist in development of regulatory standards and SOPs
  • Provide regulatory guidance to support business development and sales
present
Chicago, IL
Senior Manager, Regulatory Affairs CMC
Chicago, IL
Stracke-Feil
present
Chicago, IL
Senior Manager, Regulatory Affairs CMC
present
  • Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as In-Line projects such as site transfers
  • Work to align with the RA Technical Director to research and prepare the initial CMC strategy for timely registration of New Product with FDA, EMA and other world Regulatory Authorities
  • Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as Lifecycle management projects such as site transfers
  • Provide regulatory assessments of manufacturing changes within the change control system and filing strategy guidance to Technical Operations and Quality department, including supporting preparation for facility inspections of vendor sites by health authorities when necessary
  • Initiate local process improvement and contribute to local and/or global process improvements which have significant impact for the Regulatory Affairs Department or other departments
  • Manage relationships with key stakeholders in technical Operations and Quality and across Regulatory Affairs to provide CMC regulatory support in achieving strategic objectives
  • Work with functional experts to provide timely responses to CMC questions from regulatory agencies
Education Education
Bachelor’s Degree in Science
Bachelor’s Degree in Science
Rutgers University
Bachelor’s Degree in Science
Skills Skills
  • Knowledge of applicable regulations, current industry practices, and strong experience with interpretation and application
  • Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
  • Excellent scientific knowledge and technical system skills
  • Demonstrated strong organizational skills with ability to set priorities and meet deadlines, as well as to respond to changing deadlines and priorities
  • Strong attention to detail
  • Actively engages in professional development
  • Microsoft Office/Suite proficient (Word, Excel, PowerPoint, etc.)
  • Regulatory knowledge in national regulations
  • Great interpersonal skills
  • Excellent communication skills (written and verbal)
Create a Resume in Minutes

15 Senior Manager, Regulatory Affairs resume templates

1

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • 2+ years of Regulatory Affairs experience
  • Bachelor's Degree in Life Sciences or Pharmaceutical
  • Extensive experience in CMC Regulatory Affairs
  • Experience in global Regulatory Affairs/Drug Development including direct interactions with FDA
  • Experience with the preparation and review of regulatory submissions
  • Experience with electronic submissions and knowledge of CTD and eCTD
  • Microsoft Office/Suite proficient (Word, Excel, PowerPoint, etc.)
  • Able to multitask efficiently and effectively $
  • Advanced Degree in Life Sciences or a Health-related field
  • Background in Chemistry, Manufacturing and Controls Regulatory Affairs
  • Experience in biologics/biotech drug development projects in immunology, oncology, rare diseases, or renal disease
  • Prior interactions with regulatory agencies
2

Senior Manager Regulatory Affairs EU Resume Examples & Samples

  • Lead SRA responsibilities on food regulatory developments for the EU including
  • Continuous monitoring of the regulatory environment (early warning)
  • Leading the development of positions on EU food regulatory initiatives and facilitating internal alignment in close collaboration with relevant BUs and other relevant functions in Europe and within Corporate
  • Actively influencing along the process in all stages and with all relevant stakeholders, communicating developments internally and governing of markets regarding impact, changes and implementation
  • Maintain, enhance and develop strategic relationships/networks with external experts & stakeholders such as EU Institutions, NGOs, academics, industry and other stakeholders on issues relating to food regulatory matters to advance our company positions and create a favourable regulatory landscape
  • Provide support and expert input on critical scientific and regulatory issues (i.e. regulatory and compliance matters, regulatory opportunities) in specific countries (also outside of EU where EU legislation has a significant impact)
  • Proactively identify, develop, and execute initiatives, programs, partnerships, coalitions and stakeholder networks, with the objective of minimizing regulatory and scientific barriers and/or leverage regulatory and scientific opportunities to support our renew growth strategy. Actively represent TCCC at key regulatory discussions in industry associations/coalitions on nutrition and health as well as food safety regulatory/policy matters s to help protect our products and ingredients
  • Leverage cross-functional relationships, particularly with PAC, Legal, R&D, Technical governance, Marketing and other functions as appropriate in support of our renew category growth strategy and in order to drive our related scientific and regulatory strategy and initiatives
  • Proactively support innovation plans and identify regulatory opportunities for the successful growth of the TCCC system
  • Drives cross-discipline collaboration and teamwork: Applies understanding of scientific & regulatory processes, including internal and external relationships to advance to advance achievement of company’s and technical organization’s priorities. Demonstrated ability to establish and nurture productive cross-functional and internal and external stakeholder collaborations
  • Problem Analysis and Resolution: Ability to form an opinion or make a decision through careful testing of assumptions and facts; willingness to take action consistent with available facts, constraints and probably consequences
  • 12+ years with MS, or 10+ years with PhD in food science, nutrition or related field and relevant experience
  • Profound knowledge and experience in EU food law and regulatory matters
3

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • A minimum of a Bachelor’s degree is required, preferably in a Life Sciences related discipline. An advanced degree (MS, MBA, PharmD, MD, PhD, etc) is preferred
  • Minimum of 8 years of relevant experience, preferably within a Regulatory environment
  • Experience within Medical Devices, Pharmaceutical, and/or Consumer industries preferred
  • Minimum 3 years demonstrated ad & promotional review experience is required
  • Previous leadership or supervisory experience is required
  • Advanced level of written and oral communications skills is required
  • Demonstrated knowledge of medical device advertising requirements in the US and EU is preferred
  • Ability to work in a fast paced environment, and juggle multiple projects; strong organizational skills; ability to work independently is required
  • Ability to influence others to understand and comply with regulatory requirements is required
  • Excellent problem solving skills, ability to think creatively within established guidelines is required
  • Ability to work with a diverse set of stakeholders in different geographical regions, interpret difficult situations, and determine optimal solutions to ensure customer satisfaction is required
  • This position is located in Wayne, PA and may require up to 10% travel, domestic and international
4

Senior Manager Regulatory Affairs Resume Examples & Samples

  • A minimum of a Bachelor’s Degree in a scientific/technical/engineering related discipline or equivalent degree is required
  • A minimum of 8 years of Medical Device industry experience or related industry experience is required
  • Highly skilled in establishing partnerships with internal and external partners and the ability to work collaboratively in a matrix environment is required
  • Masterful communication, organizational, negotiation and interpersonal skills are required
  • Expert knowledge and hands on experience obtaining regulatory approvals for medical devices is required
  • Strategic Thinking with demonstrated ability to set effective business, technical and/or regulatory direction is required
  • Proven record of effectively negotiating and influencing upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met is required
  • Must be able to communicate clearly and effectively over the phone and in written in English
  • Experience in the field of optometry and contact lenses is a plus
  • This position is located in Jacksonville, FL and may require up to 15% domestic and international travel
5

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Develop and communicate Global UDI requirements and provide ongoing global regulatory labeling strategies and plans for complex UDI implementation programs as well as new product development. Integrate key labeling requirements and best practices into global UDI and labeling strategies
  • Help formulate and drive global UDI initiatives as well as global labeling traceability requirements within project and product teams
  • Represent or lead the RA labeling function on assigned cross-functional project teams and projects. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team
  • Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects
  • Effectively perform gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications
  • Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
  • Strong oral and written communication and presentation skills
  • Ability to independently identify compliance risks and escalate when necessary
  • Ability to lead and coach others
  • Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5-7 years regulatory experience in RA or related field, including managing people or projects. Direct experience with global device labeling will be an advantage
6

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Establish company policy to ensure that the company meets the regulatory requirements for Medical Devices products sold onto the Asian Market
  • Setting strategy and direction for the team and also looking at the compliance aspects for the different regions in Asia
  • Ensuring that the new product registration is performed on time before the launch
  • Ensuring the product meets all legal obligations for sale in Asia like Product regulations, registration, labeling and barcode
  • Work closely with government bodies, regulatory authorities and associations, International standard Organizations (ISO)
  • Carrying out ISO audit of facilities such as 3rd Party Warehouse and related areas
  • Participate in due diligence of acquisition for product regulatory compliance
  • Ensuring active membership of design teams for Pall Medical and Pall International product to ensure that regulatory requirements are met in the design phase
  • Ensuring that subcontractors meet regulatory compliance requirements and are approved by regulatory affairs at the initiation stage
  • Degree in Biology, Chemical, and Polymer related studies
  • Hands on experience in ISO procedures would be a big plus
  • Prior experience in Regulatory affairs and quality assurance
  • Willingness to travel across Asia
  • Good team player and ability to work in an autonomous manner
  • Ability to manage the team virtually
7

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Formulate, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
  • Identify as early as possible, the required documentation and any content, quality and/or timeline issues. Negotiate the delivery of approved technical source documents in accordance with project timeline
  • Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities
  • Review and provide input on proposed health authority guidance documents on CMC issues
  • 8+ years pharmaceutical industry and 6+ relevant regulatory CMC experience
  • Advanced degree highly preferred ( MS, Pharm.D, Ph.D. or equivalent)
8

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Responsible for developing product regulatory strategy for surgical devices
  • Develop a product regulatory timeline aligned to the company’s product development, with key regulatory milestones, and activities for agency filing
  • Coordinate with the team on the development of product labels in accordance with regulatory requirements
  • Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
  • Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections
  • Provide regulatory guidance/input to surgical device change control and internal product review boards
  • 10+ years relevant medical device industry and regulatory experience; 5 + years in Class II and III devices
  • Ophthalmic device regulatory experience, a plus
  • Bachelor’s degree in science or health related field; advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)
9

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Supervise, evolve and track integrity of audit of Quality System (DIN ISO standards 9001 and 13485) within internal organization and of external service provider including the customer service organization with more than 100 agents working on behalf of Abbott at SITEL
  • Builds sustainable Regulatory Affairs, Quality & Compliance infrastructure for DACH by developing policies, procedures and guidelines in consultation with GM, Global QA/ RA team
  • Liaises with global and communicates local regulatory requirements and ensures appropriate implementation in line with external and internal requirements
  • Supports evolution of ADC business critical transformation to a direct-to-consumer and direct-to-patient business actively establishing and implementing new appropriate quality standards according to internal and external regulatory standards
  • Contributes to evolution of our Quality System MIMS (Multisite Integrated Management System) to ensure it appropriately supports DACH regulatory and business requirements
  • Supports GM Germany in ensuring ADC meets local compliance standards of Environmental, Health & Safety (EHS), Affiliate Compliance Committee (ACC) requirements and other legal requirements. Drives critical improvements in compliance management analyzing changes in local regulatory framework. Interacts with EHS department and Compliance Manager
  • Manage business critical field actions coordinating relevant teams including functions from sales, marketing, medical, customer service, regulatory and public affairs
  • Ensure preparation of any internal or external Regulatory or Quality Audit
  • Degree in Natural Science, Medicine or Engineering
  • Knowledge of regulatory requirements (e.g. MPG, IVD guideline), internal & external compliance regulations and quality standards
  • Extensive project management experience
  • Solid know-how in Regulatory, compliance and quality affairs of diagnostic, pharmaceutical or medical device industry, execution and documentation of field actions
  • Working Experience in a commercial organization with a strong customer focus
  • Ideally knowledge of the diabetes market
  • Organizational skills and high level of quality awareness
  • ONESTEP & other internal quality management systems (ETMS, etc.)
  • Ability to lead cross functional teams under tight timelines
  • Effective and motivating interpersonal communication skills
10

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Responsible for, or contributes to execution of development & submission strategies in EU for projects assigned
  • Works with Regulatory Strategy Leader & Regulatory Projects Team leadership to ensure that development programs & product life-cycle plans are aligned with regulatory requirements
  • Contributes ideas to the design of innovative regulatory pathways
  • Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, e.g. GPT as requested
  • May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues. Participates in global regulatory Therapeutic Area (TA) team
  • Develops & contributes 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 review of documents before submission
  • Reviews draft protocols, acts as Regulatory Project Team representative in clinical study teams and liaises with the Clinical Trials Applications (CTA) group
  • Acts as subject matter expert on designated studies in the event of a Health Authority inspection
  • Responsible for tracking & communicating regulatory activities within RA & for accurate submission plans in eQRMS
  • Responsible for or participate in interactions with Regulatory Authorities, including agency meetings
  • Supports or is responsible for the optimisation of product information achieved through negotiation with internal stakeholders & Regulatory Authorities
  • Supports or may be responsible for ensuring that Celgene fulfils Health Authority commitments
  • Participates in regional launch team
  • Responsible for the regulatory review & approval of commercial advertising & promotional literature
  • May be responsible for leading, managing & coaching Regulatory Projects Team staff as assigned
  • Monitors resource needs for projects assigned through discussion with manager
  • May contribute to planning & monitoring the budget for the TA Regulatory Projects Team
  • May participate in cross-functional initiatives
  • LI-SL1
  • PHW
  • Experience in EU Regulatory Affairs & recent experience of EU Centralised Procedure required
  • In-depth knowledge of current EU regulatory requirements essential
  • In-depth understanding of CTD modules; non-clinical, CMC, Clinical
  • Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required
  • Knowledge of TA for projects assigned
  • Experience of leading projects through Regulatory Procedures
  • Experience in Haematology/ Oncology or Inflammation/ Immunology preferred
  • Experience of contributing to Ph III protocols & able to contribute to clinical development plans
  • Actively engages in professional development
  • Seeks opportunities to learn from others
  • Effective project manager, developing leader. Creates project plans, prioritises effectively, leads teams in project execution & delivery
  • Ability to lead complex regulatory submissions. Leads activities for assigned projects
  • Conveys trust in others’ knowledge, skills & judgment & provides team members with appropriate levels of autonomy & decision-making authority
  • 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
  • Identifies when to escalate issues to line management & knows when to seek advice
  • Communicates complex ideas effectively across a culturally diverse environment
  • Communicates effectively with Regulatory Authorities as required
  • Ability to influence internal & external stakeholders to obtain desired outcome
  • Exhibits consistent professional behaviours
11

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Act as Regulatory Project Lead but may also report to another Regulatory Project Lead as required
  • To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines
  • As a manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
  • Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken
  • Management of the designated project in accordance with the agreed project planning and control documentation, including initiation and maintenance of the project plan
  • Management of the assigned regulatory project team
  • Ensuring that checking and auditing procedures are carried out
  • Monitoring and advising on compliance with agreed budget relating to the project
  • EU/APAC: In depth proven experience in regulatory affairs or aligned work
  • Good written and spoken English
  • Bachelor’s degree, or local equivalent, preferably in the sciences, or equivalent experience qualification. Masters degree or higher preferred
12

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Function as global CMC lead on program teams
  • Strategize on deliverables to ensure Module 3 content meets regulatory requirements
  • Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
  • Collaborate as a trusted and respected peer with R&D, CMC teams, Manufacturing and Quality Assurance to establish appropriate risk-based solutions which account for regulatory requirements
  • Work to integrate regulatory CMC requirements and expectations throughout the organization
  • Serve as lead CMC regulatory representative on cross-functional product teams, and applying advanced knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with government regulations
  • Participate at the global regulatory teams representing CMC and participate in regulatory authority meetings for major CMC meetings
  • Oversee development and negotiation of overall plans regarding CMC to assure viability for global or regional registrations for select program
  • Align CMC regulatory strategy to overall regulatory business strategy
  • Interpret new regulatory policies and trends and as they apply to company products and procedures for impact and/or potential change in approach
  • Knowledge of applicable regulations, current industry practices, and strong experience with interpretation and application
  • Excellent scientific knowledge and technical system skills
  • Excellent risk management discipline and problem solving skills
  • Ability to function as a team member and lead where needed
  • Experience in interacting with Regulatory Authorities
  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 7 to10 years of regulatory or equivalent experience or PhD with 3years within a pharmaceutical company
  • Experience with registration of Monoclonal Antibody applications with regulatory agencies are highly required
  • Experience in quality or contract manufacturing environment and regulatory inspections and audits
13

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Regulatory Affairs (RA) team lead on software development project core teams
  • Manage product regulatory submissions as part of the Corporate Headquarters Regulatory Affairs team
  • Work with regulatory colleagues to develop innovative regulatory strategies for New Products (NPI) to drive business growth; assist markets in product registration planning, claims assessment and innovation, developing registration dossiers for submission, monitoring the progress, status and timelines
  • Participate as the regulatory subject matter expert during audits or inspections to ensure compliance with relevant product regulations (e.g., compliance with US FDA QSR, Europe IVDD/MEDDEV, Canada Med Dev Regulation, ISO 13485 & 14971, etc.)
  • Compile evidence, prepare, submit and track annual reports according to requirements of regulating bodies
  • Monitor and assess design and process changes – with emphasis on IVD software – for regulatory impact
  • RA team lead in compiling and preparing hardcopy and electronic information packages for submission to regulatory agencies
  • Define, monitor and receive deliverables for submissions
  • Interact with regulatory agencies and third party accrediting bodies
  • Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement
  • Monitor advertising and promotional materials for compliance with product claims
  • Provide regulatory guidance to support business development and sales
  • Provide training and updates on key regulatory legislation, systems, processes and/or projects (as appropriate)
14

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Independently manage multiple projects and submissions primarily for Alexion’s commercial and investigational products
  • Plan, coordinate, and manage the development, preparation and submission of the Chemistry, Manufacturing, and Controls (CMC) sections of Alexion’s registration dossiers, supplements, and renewals for commercial products. Dossier preparation will include new country submissions and post-approval changes
  • Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight. Present CMC strategies and plans to Alexion management and appropriate core teams
  • Effectively build and lead project teams for CMC submissions
  • 8-12 years related experience in a scientific discipline with additional technical / project education or training; with a minimum of 5 years of experience in Regulatory, Regulatory-CMC or a Quality Compliance function
15

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Identify as early as possible, the required documentation and any content, quality and/or time-lineissues. Negotiate the delivery of approved technical source documents in accordance with project time-line
  • Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product life-cycle, with awareness of pre-clinical, clinical, commercialization, and operations
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Capacity to react quickly and decisively in unexpected situations
  • Advanced degree highly preferred ( MS, Pharm. D., Ph.D. or equivalent)
16

Senior Manager Regulatory Affairs Amac Resume Examples & Samples

  • Develop and drive regional regulatory strategies for New Product across AMAC in close collaboration with the respective Sub-region Heads
  • Identify opportunities and challenges to meet submission & approval targets in order to ensure successful launch
  • Partner with Sub-region heads to implement set plans and to develop mitigation plans when appropriate
  • Provide Subject Matter expertise in product development for assigned portfolio to region and in regional requirements to global development organization
  • Provide comprehensive regional regulatory input into global Regulatory Functional Plan, ensuring key country specific requirements (e.g. local patients, bridging reports, GMP inspections, etc.) are known and considered early enough during drug development to meet business targets as planned
  • Partner with regional commercial organization to ensure business objectives are understood and taken into account during development of regulatory strategy. Provide comprehensive regulatory advice impacting commercial planning
  • Identify and leverage opportunities for cross-country, cross-regional cooperation and synergies with Sub-region Heads
  • Act as Primary AMAC Lead for key stakeholders in global regulatory franchises (with GPRMs and GPRDs) and AMAC commercial colleagues for assigned portfolio
  • Liaise with global RA teams and/or regional commercial organization to ensure the necessary support to countries to execute regional strategies
  • ‘Translate’ complex global development information into tangible actions and strategic considerations for countries and sub-region heads
  • Represent RA AMAC in Regulatory sub-teams for key projects/products and provide relevant regional input
  • Ensure transparent, complete and timely communication to regional team, management and key stakeholders
  • Facilitate Best Practice sharing across region and with other regions
  • Deliver capability building and training opportunities to countries within region
  • Partner with Sub-region Heads to increase regional regulation awareness within global organization
  • Minimum 5 years’ experience in Drug Development. In depth Regulatory experience preferred
  • Deep understanding of regulatory environment in region an advantage
  • Ability to work in cross-functional, multi-cultural environment
  • Highly committed and team-oriented
  • Excellent communication and negotiation skills
  • Ability to develop and communicate regulatory strategy
  • Shows cultural awareness
  • Strong analytical skills, strategic thinking
  • Experience with Asia, Middle East and/or Africa an advantage
17

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations
  • Pertinent Federal and State laws related to pharmaceutical regulatory affairs
  • Supervision and training practices and methods
  • Business, scientific and personal computer software applications
  • Business English usage such as, spelling, grammar and punctuation
  • Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods
  • Company policies, practices and procedures, including safety rules and regulations
  • Principles and practices of budget preparation and administration
18

Manager / Senior Manager Regulatory Affairs Resume Examples & Samples

  • PharmD/BS degree in a scientific discipline
  • Minimum 8 years pharmaceutical industry experience: 5+ years Regulatory Affairs required coupled with 2 years Analytical, QA, laboratory, or production experience preferred
  • Minimum 3 years pre-approval Regulatory experience with ANDA or 505(b)1/505(b)2/351(a) and/or 505(j) applications is required
  • Previous 510K experience is preferred
  • Injectable/sterile product experience required; however, BLA/Biosimilar experience will be considered
  • Previous Managerial experience preferred
  • Exhibits strong knowledge of current regulations and guidances related to the filing, approval process, and maintenance of ANDAs
  • Demonstrates a basic understanding of pharmaceutical drug development
  • Basic computer skills such as Word, Excel, Power Point, and familiarity with the internet
  • Ability to manage timelines within a project team environment
  • Ability to work independently and on teams
  • Ability to effectively liase with FDA, various disciplines within Teva, and third parties
  • Ability to establish and maintain good working relationships
  • Demonstrates good negotiation and management skills
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities
19

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Provides direction and leadership to facilitate market clearance and product registration activities for product commercialization within North and South America
  • Executes all registration and licensing requirements as they apply to products and services of the company both domestically and internationally, as well as facility licensing activities
  • Provides early guidance concerning regulatory requirements, e.g., submissions, claims identification and substantiation, labeling, promotional materials and assuring the validity of clinical, ethical and regulatory compliance issues
  • Reviews and approves all labeling for compliance, including all communications to trade publications, news media release, sales presentations and technical bulletins
  • Analyzes the support data for claims verification
  • Collaborates with and assists Global Regulatory partners to support product compliance internationally
  • Manages departmental spending to the established budget
  • Manages Regulatory Affairs/Quality Systems Department budget
  • North and South America regulatory responsibility, but interfaces with global team
  • Span of control: Document and Data Control, Regulatory Affairs (Americas), FDA Official Correspondent
  • Span of influence: R&D input related to US and Canadian registrations, Global Regulatory Affairs (consults/coordinates on global regulatory licensing and registration strategies)
  • Direct reports may include Documentation Specialist(s), Regulatory Affairs Associate(s), and Regulatory Complaints Specialist(s)
  • Trust and Integrity
  • Negotiation/Influence
  • Managing Others
  • Global/Business Perspective
  • Computer Skills – Proficient computer system based tools including Microsoft Office applications, presentation, e-mail, web browsers and spreadsheet software
  • Minimum of 8 years of Regulatory experience in the food, drug, or device industry required
  • History of success in making change and achieving objectives required
  • Successful track record working in a matrix/collaborative environment required
20

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Support the program EU regulatory leads in executing on program strategy and deliverables, may take the lead on the strategy and execution of deliverables for one or more programs as required by the needs of the business and the EU regulatory team
  • Ensure European regulatory requirements are identified and implemented into development and pre and post-authorization regulatory activities
  • Contribute to the strategy, planning, preparation, submission and maintenance of MAA’s, CTA’s, ODD’s, PIPs, Regulatory Agency meetings, Protocol Assistance etc as required for assigned programs
  • Represent the EU RA department in cross-functional project teams, engage with and give regulatory support to program regulatory and development teams, and commercial, medical and clinical colleagues
  • Support process improvement initiatives, standards development, and metrics
  • Interact with staff from EMA and other EU national agencies
  • Provide guidance to all appropriate departments in BioMarin to ensure compliance with applicable regulations
  • Remain knowledgeable about current and evolving EU regulations and guidance
  • Extensive regulatory experience gained within a Pharma/Biotech Company or with an EU regulatory authority
  • Experience of both development and pre-/ post-authorization activities, in particular with a track record in execution of strategy for development products
  • Orphan drug experience is preferable
  • Skilled at gathering supportive information and developing EU regulatory approaches for development and pre- and post-authorization activities,
  • Proven ability to manage critical projects as a part of a multifunctional (matrix) team
  • Proven ability to successfully interact with regulatory authorities
  • Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
  • Ability to multitask; manage multiple products and deliverables and independently resolve problems and identify areas of opportunity
  • Proficient with computer and standard software programs. Experience with electronic submissions such as eCTDs and working with an electronic Document Management System is desirable
  • Outstanding interpersonal, negotiation and communication (written and verbal) skills
21

Senior Manager, Regulatory Affairs Ad / Promo Resume Examples & Samples

  • Supports interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s)
  • With oversight from Director level or above, develop regulatory strategies and provide guidance to other departments
  • Manage timelines and resources to achieve stated goals
  • Foster and facilitate teamwork between Regulatory and CRC partner functions
  • Provide regulatory advice and support to commercial teams and the Copy Review Committee (CRC), with oversight
  • Develop departmental guidance and procedures
  • Manage regulatory aspects of the copy review / approval process for product promotional materials for assigned products, indications, or audiences. Ensure compliance of promotional materials with the governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion
  • Design and conduct departmental training
  • Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape
  • Bachelors degree (BA or BS). Scientific discipline preferred
  • 3-7 years of pharmaceutical industry experience, with 2-4 years in regulatory affairs preferred
  • Knowledge of FDA advertising and promotional regulations and guidance is necessary
  • Must be able to innovate, analyze, and solve problems with minimal supervisory input
  • Excellent communications, listening, and negotiation skills are necessary
  • Leadership skills required
  • Excellent organizational, and time management skills needed to manage multiple ongoing projects simultaneously
  • Must be an innovator of new ideas and best practices
  • Must recognize potential problems
  • Must have outstanding attention to detail
  • Domestic travel may be necessary
22

Senior Manager, Regulatory Affairs CMC Resume Examples & Samples

  • Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as In-Line projects such as site transfers
  • Participate in Project team and lead technical task force meetings leading on RA/CMC related activities
  • Work to align with the RA Technical Director to research and prepare the initial CMC strategy for timely registration of New Product with FDA, EMA and other world Regulatory Authorities
  • Provide leadership to rapidly adapt strategy to unanticipated changes
  • Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely world-wide registration
  • Work with functional experts to provide timely responses to CMC questions from regulatory agencies
  • Support transfer of manufacturing processes and analytical methods from R&D to Industrial Operations
  • Writes CMC dossier from CMC data package and coordinate a comprehensive project team review by functional team members to ensure accuracy of the filed dossier
  • Participate in and manage post-approval product activities such as, but no limited to, change control, supplements and variations for global products as well as questions from regulatory authorities where appropriate
  • Provide regulatory CMC expertise during Regulatory Affairs negotiations and interactions with regulatory agencies
  • As CMC Technical representative to assigned New Product Development teams, communicate with internal and external customers to obtain required supporting documents and data for compilation of the CMC dossier in a timely manner that supports agreed upon project timelines
  • Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities
  • Represent Merial position and interests in external trade organizations or regulatory professional societies. Keep up to date on industry and regulatory trends
  • Provide regulatory CMC expertise during due diligence and in support of new projects
  • Ph.D. with four years experience or Master Degree with six years experience or Bachelor Degree with eight years technical experience in chemical disciplines
  • Exceptional written and verbal communication skills including ability to persuasively communicate
  • Effective interpersonal skills with the ability to work in a team-based setting; flexibility; achievement-oriented with appropriate concern for quality are
  • Computer literacy required
  • In addition to above: Record of achievement of regulatory approvals and demonstrated success in working with regulatory authorities and/or toll manufacturers
  • In depth knowledge of U.S. and European Regulatory and pharmaceutical issues
  • CMC support of new pharmaceutical and/or marketed pharmaceutical products worldwide
  • Extensive customer interactions with R&D functions, QA, Manufacturing and other teams within Regulatory Affairs
  • External influence in trade organization or regulatory professional societies
23

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Minimum 5+ years’ pharmaceutical/biotechnology industry experience, 2 years regulatory experience
  • Demonstrate excellent communication skills
  • Ability to represent the department on project teams
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
  • Demonstrate effective cross-cultural awareness and capabilities
  • Some direct experience in interfacing with relevant regulatory authorities
  • Good knowledge and understanding of applicable regulations
24

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Proficient in MS Word, Excel, PowerPoint, MS Project, Liquent, and Trackwise
  • Excellent organizational and communication (written and verbal) skills
  • Demonstrated ability to work successfully on project teams
  • RAC certification preferred
  • Previous experience working in a fast paced environment on multiple product lines
  • Manufacturing, QA/QC experience, regulatory strategy development experience
25

Senior Manager Regulatory Affairs CMC Resume Examples & Samples

  • Leads, implements and drives regional and/or global CMC strategy & submission activities, including planning, writing, review, coordination and submission of CMC sections of Briefing Packages, meeting requests, INDs, NDAs/ BLAs, CTAs, MAAs and other regulatory filings for assigned development projects and marketed products
  • Interfaces with Health Authority project managers and CMC reviewers to facilitate approval of regulatory submissions and coordinates responses to Health Authorities with appropriate Teva personnel and departments to resolve outstanding regulatory issues
  • Arranges for, coordinates and leads teams in planning, preparation, and execution (lead facilitator) of meetings or teleconferences with Health Authorities (e.g., FDA, EMA)
  • Represents regulatory CMC and provides US regulatory filing strategy recommendations to interdisciplinary project teams. Coordinates global regulatory strategy development with relevant groups to ensure consensus on critical issues, and identification and communication of regional differences including implementation plans
  • Bachelor’s Degree in scientific field, such as biology, biochemistry, biotechnology, cell biology or equivalent, PharmD, Ph.D., or Master’s degree preferred
  • 7 years (or equivalent combination of education and related work experience) of biopharmaceutical industry experience in new drug regulated product strategy and submissions; including working knowledge of U.S. laws, FDA regulations and guidance applicable to registration and approval of drugs or biologics
  • Working knowledge/experience in regulatory submissions and approval processes for biopharmaceuticals and ability to deal with complex CMC regulatory issues and requirements
  • At least 7 years in regulatory affairs with proven experience in successful filing and defense of major submissions -- IND / NDA / BLA / CTA / MAA
  • Strong background in biopharmaceutical development with focus on CMC aspects
  • Experience implementing principles embodied in ICH Guidances Q8, 9, 10, including QbD
  • 2-4 years project management experience
  • Exposure to biosimilar development
  • Working knowledge of relevant drug and biologic laws regulations and guidances / guidelines
  • GCPs, GMPs, GLPs
  • RAC
26

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Provides review of materials for medical, nutritional and biochemistry-based accuracy and substantiation of all claims
  • Regulatory and medical reviewer for all labeling materials created for nonprescription products, such as OTC drug products, dietary/nutritional supplements, foods, and/or cosmetics which MCH commercializes through retail, professional, and e-commerce chains
  • Serve as the regulatory and medical reviewer for all advertising and promotional materials created for nonprescription products, such as over-the-counter (OTC) drug products, dietary/nutritional supplements, foods, and/or cosmetics which MCH commercializes through retail, professional, and e-commerce chains
  • Provides review of materials for adherence to applicable regulations and guidance documents and for other regulatory requirements
  • Provide nutritional and biochemistry-based technical support for all Consumer Healthcare products
  • Provides general regulatory affairs support for MCH
  • Manages the filings and applications with the FDA and other government agencies, submission of required reports to the agency, Pharmacovigilance support, etc
  • Strategic regulatory and scientific technical support in terms of new product opportunities, dietary supplement research and development, due diligence, product launch, etc
  • Bachelor’s degree or equivalent in a scientific field of study and 4-7 years of experience are required. Master’s degree preferred. Related experience may also be considered
  • Knowledgeable in FDA regulations as pertaining to dietary supplements (foods), OTC drugs, and cosmetics
  • Must have excellent collaboration, influencing and negotiation skills, and be able to establish and maintain collaborative working relationships with intra-department, inter-department, and external third party personnel
  • Ensures timely submission of appropriate regulatory documents
  • Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
  • Knowledgeable in Health Canada regulations as pertaining to drugs and natural health products
  • Some physical demand. Often lifts light-weight material up to 20 lbs. May involve walking, standing, carrying, pushing, and/or pulling
  • Proficiency in speaking, comprehending, reading and writing English is required
27

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Act as the process owner of Global Regulatory Council (GRC), Product Labeling Council (PLC), Pre-Market Notification (PMN) and Global Product Registration System (GPRS). Continuously improve the processes and update the relevant SOP or Procedures
  • Provide direction regarding pre-market regulatory policy and practices for all operations ensuring the development and implementation of advanced and aggressive regulatory strategies that provide a competitive edge to Beckman Coulter
  • Understanding BEC products and technologies and current processes of product development and product submission registration among all product lines. Ability to process mapping the registration process and standardize it with a best practice for all product registrations
  • Ensure business teams consider the impact of current or emerging regulatory issues, works with management from all sites to facilitate and ensure company practices are consistent with the corporate regulatory risk posture
  • Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required
  • Work with appropriate functional management to address labeling discrepancy issues in a timely fashion
  • Lead the global product registration team in tracking and managing Global Product Registration System (GPRS) for needed updates or upgrade
  • Be responsible for monitoring, tracking and updating the global product registration database for the needed visibility and managing regulatory compliance risks
  • Communicates and reports regularly to executive management, users and staff on the status of the quality system
  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
  • Assure that there are no significant interruptions to the business due to quality or compliance issues
  • Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations
  • Subject matter expertise in regulatory affairs for medical devices
  • Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devise and diagnostic development
  • Experience in the, registration and commercialization of medical device and diagnostic products
  • Ability to develop effective regulatory strategies and apply regulations to pre-market and post-market strategies
  • Possess a broad knowledge of surrounding area including Quality Assurance, Manufacturing and Development
  • An established personal relationship with the FDA and experience with IVD products
  • Multi-tasking with flexible working hours to cover various time zones globally
  • Proven leadership and managerial skills in order to build and sustain a vision for the work group
  • Demonstrated track record of developing organizational capability
  • On-Time Deliverables are critical to this position
  • Critical thinker able to address complex situations and issues
  • Express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings
  • Acts decisively, holds position and challenges others appropriately
  • Develop strategic goals and objectives from knowledge base and understanding of a customer’s business
  • Manage changing conditions, processes and approaches; lead organizations through change effectively
28

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Preparing and assisting in the preparation of high quality Latin-America and US submissions
  • Liaise proactively with internal cross-functional teams as well as external partners supporting development activities
  • Identify potential regulatory risks and propose options to mitigate risks
  • Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
  • Assume assigned responsibilities for routine and non-routine contact with health authorities including coordinating and managing health authority meetings
  • Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
  • Delivers project assignments supporting the business e.g. representation on functional work streams
  • Assist in development of regulatory standards and SOPs
  • Assist in due diligence activities for in-licensing opportunities
  • Bachelor’s degree in Science or related discipline
  • 5+ years pharmaceutical experience
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations
  • Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Results focused – ability to overcome obstacles and achieve key outcomes
  • Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Organizational Skills -
  • Integrity – overriding commitment to integrity and high standards in self and others
  • Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
29

Senior Manager Regulatory Affairs & Project Mgmt Resume Examples & Samples

  • Function as the Global Process Owner (GPO) for global regulations and Global Regulatory Council (GRC). Maintain and improve the process; chair scheduled meetings, track the progress of major projects, and update the SOP accordingly
  • Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively
  • Liaise with the regional and geographical Q&RA organization to support and ensure alignment with BEC global policies and procedures
  • Maintain current knowledge of FDA and international regulations, guidance documents and standards applicable to company products
  • Participate in research of regulatory issues and dissemination of regulatory information to the various departments and senior management as required
  • Works with minimal guidance and expands knowledge and skill sets beyond own area
  • Supervise Regulatory Affairs associate and/or interns as required
  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes; developing regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals
  • Assure that there are no significant interruptions to the business due to compliance issues
  • A Bachelor’s degree with 14+ years of experience, Master’s degree with 12+ years of experience, AND at least 4+ years managing people
  • Professional designations are not required but training and certificates in quality or Regulatory Affairs are desired. (e.g. CQE, CQA, RAC, Six Sigma, Lean Principles)
  • Project Management experience and a proven track record for driving completion required
  • Comprehensive understanding of reagent manufacturing processes and principles
  • Subject matter expertise in Regulatory Affairs for medical devices or in vitro diagnostics
  • Demonstrated knowledge and understanding of Global regulations and guidelines governing the areas of medical devices or in vitro diagnostics
  • Experience in registration and commercialization of medical device or diagnostic products. Must have a hands-on experienced in both pre-market product registrations and post-market surveillance program in the IVD industry
  • Possess a broad knowledge of other functional areas including Quality Assurance, Manufacturing and Development
  • Demonstrated track record of developing organizational understanding and capability as it applies to Regulatory Affairs
  • Global experience leading and/or participating on cross functional teams
  • Must possess excellent communication (both written and verbal), influential and negotiating skills, allowing the effective communication of complex regulatory information to a wide variety of audiences and leveraging for the best outcome
  • Critical thinker able to address complex situations and issues.Must be a strong collaborative facilitator and leader, building consensus while championing global regulatory compliance
  • Capable of multi-tasking, on-time delivery, and applying the learned knowledge effectively
  • Manage changing conditions, processes and approaches
  • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals
30

Regulatory Regional Senior Manager Regulatory Affairs Resume Examples & Samples

  • Seven to 10 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience
  • Extensive experience with drug development and strong working experience with CBER requirements
  • Experience managing projects from early development through BLA approval with a strong biological business orientation
  • Demonstrated working knowledge of regulatory guidelines and legislative requirements for regional regulatory authorities
  • In-depth knowledge of GMP, GCP and GLP
  • Demonstrated ability to deal with rapid change
  • Demonstrated sound judgment and flexible approach to managing situations
31

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • 6+ years significant experience in regulatory affairs, or appropriate relevant experience
  • Requires scientific and regulatory knowledge pertinent to development aspects, particularly CMC
  • Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to CMC product development, preferably vaccines/biological
  • Experience in liaison with major regulatory Agencies, preferably FDA
  • Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent
  • Ph.D; Pharmacy, Chemistry, Biology or Medicine
  • Experience in providing strategic advice on integrated regulatory development plans, and problem solving in cross-functional teams in drug/vaccine development
  • Ability to assess and determine regulatory strategy for reporting of postapproval CMC changes
  • Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy
  • Good influencing skills
  • Enterprise thinking – needs to and the potential impact on RA, including how RA may facilitate in achieving the overall goal
  • In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions
32

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Represent regulatory affairs on product development and commercialization teams related to Transcatheter Mitral and Tricuspid Therapies
  • Interacts with FDA and/or other regulatory bodies for submissions and projects
  • Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned
  • Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation
  • Able to collaborate and take direction from team leaders, while working with RA management on RA strategy for US IDE, US PMA, CE Trial, CE Mark, as required
  • 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 and Justifications to File
  • Assume regulatory review of promotional material, labeling content, product and process changes and product documentation
  • Work on multiple projects where analysis of situations or data requires an evaluation of intangible variables
  • May work on new/emerging technology that has no or limited history
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Requires a minimum of twelve years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered
  • Experience in preparing domestic FDA and EU product submissions required
  • A Bachelor’s degree is required, preferably in a scientific discipline
  • Demonstrated competence in working as part of a focused, project team
  • Demonstrated understanding of basic regulatory requirements for promotional materials
  • 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
33

Senior Manager, Regulatory Affairs, CMC Resume Examples & Samples

  • Experience and knowledge in general Medical Devices essential
  • Experience and knowledge of classification of medical devices, including borderline products and SaMD a distinct advantage
  • Experience and knowledge in Digital/e-Health products, In-Vitro Diagnostics, Combination drug delivery devices and use of devices in Pharmacological Clinical Investigations highly desirable
  • Experience in interfacing with relevant global regulatory authorities and Notified Bodies essential
  • Experience and knowledge in the preparation of global regulatory submissions is essential
  • Knowledge and understanding of current and future applicable global regulations essential, especially MDR/IVDR
  • Experience of managing medical device and combination device/drug post market surveillance/vigilance issues is essential
  • Familiarity with medical device cGMP systems such as ISO13485 highly desirable
34

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Provides regulatory review and oversight for product-related changes to three biomaterials manufacturing facilities, supporting PMA, 510(k) and CE Class III medical devices
  • Develops the regulatory strategy and reviews all design transfer activities related to tissue-based New Product Introductions
  • Actively participates in New Product Introductions and Design Control activities for select tissue technology products
  • Authors PMA and design dossier regulatory submissions related to new manufacturing and manufacturing changes
  • Collaborates and assists in international registrations
  • Coordinates roll-outs of product changes with corporate and international regulatory teams
  • Responsible for maintaining regulatory approvals and lifecycle management for select tissue technology products
  • Works in partnership with Manufacturing and QA/QC to ensure overall regulatory compliance
  • Initiates regulatory reviews and input for CAPAs, investigations, and health hazard evaluations related to regenerative tissue technology products
  • Minimum of 10 years regulatory experience with increasing responsibility in the medical device industry, and 3 years previous management experience (or equivalent)
  • 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, (PMAs), Investigational New Drug (IND), or New Drug Applications (NDA)
  • Experience in working with cross-functional teams; especially with manufacturing sites
  • Experience with tissue products, including collagen products, is preferred
  • Must possess and demonstrate an excellent understanding of requirements specifically related to Class 3 medical devices: FDA requirements, ISO Standards, requirements of the Medical Device Directive (93/42EEC) and other international requirements
  • Experience in interacting with FDA and Notified Bodies
35

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Obtain updated information on changes to applicable regulations and standards to ensure continuing compliance. Present major regulatory issues or changes to applicable regulations and standards to management & executive staff with recommended actions as required
  • Manage process to maintain all applicable federal Facility Registrations and Listings, and State Licenses
  • Manage interface with regulatory agencies and certifying bodies for site inspections, presentations, and submissions, as well as matters regarding compliance with quality system requirements, and product problems
36

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required
  • Manages IVD product strategies for submissions, registrations, and maintenance globally
  • Prepare regulatory submissions for US (e.g. 510k, PMA) and Health Canada (e.g. Class III) approvals for QIAGEN IVD products including reagents and instrumentation/software
  • Prepare technical documentation needed to demonstrate compliance with applicable European Directives
  • Interface with Regulatory Agencies for inquiries/issues and provide support in customer facing issues
  • Represent Regulatory Affairs during management of the IVD product change process
37

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Bachelor’s Degree with a major in an analytical field of study from an accredited college or university is required; advanced degree is preferred
  • Minimum 5 years of relevant experience in Regulatory Affairs with pharmaceutical or biological products
  • Demonstrated strong understanding of regulatory requirements in the US, particularly with respect to advertising, promotion, and other publicly communicated materials as well as product labeling; ability to interpret and apply the regulations to specific Company projects
  • Excellent written and oral English communication skills
  • Proven attention to detail, while at the same time seeing the big strategic picture
  • Demonstrated strong organizational skills with ability to set priorities and meet deadlines, as well as to respond to changing deadlines and priorities
  • Demonstrated negotiation and problem-solving skills
  • Ability to work well independently with minimal supervision
  • Sound working knowledge of writing and publishing computer applications
  • Proven ability to communicate well with colleagues across multiple disciplines in the organization
38

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Develop and execute global regulatory labeling strategies and plans for complex projects including new products and ongoing global compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies
  • Drive regulatory promotional strategies for the review, approval, and submission (as needed) of advertising and promotional materials across products and product types. Evaluate technical and scientific information in support of product claims
  • Formulate and drive global UDI initiatives as well as global labeling traceability requirements within project and product teams
  • Represent or lead the RA labeling function on assigned cross-functional project teams and projects. Represent Baxter in relevant external industry workgroups, as needed. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team
  • Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key global labeling strategies and initiatives
  • May provide matrix or project related supervision of individuals
  • Ability to manage complex projects and timelines in a matrix team environment. -Strong project management and organizational skills
  • Bachelor’s degree or country equivalent with 5+years of regulatory experience and 8+ years of related professional experience in related field(s), including managing people or projects
  • Direct experience with global device labeling will be an advantage
39

Senior Manager Regulatory Affairs Resume Examples & Samples

  • To act as system authority, advising CN departments on legislation, rules and regulations affecting Operations and how best to manage compliance to protecting company’s financial and operating interests. Ensure HQ departments and field regulatory officers are kept informed of latest regulatory requirements and how they will impact upon operations. Assess the related corporate impacts of proposed initiatives or activities
  • Within the framework of Canadian and US Federal regulatory acts, represent CN in discussions and working groups with regulators and railway industry to develop and advance new regulations or carry out modifications to existing regulations which best ensure that CN’s interests are protected. Lobby regulatory agencies for change that benefits the railway. Develop and file applications for exemptions to rules and standards
  • Oversee response to requests for data or information from various regulatory agencies including CN comments on TSB draft accident reports and Transport Canada system safety audits
  • Manage CN’s handling of Transport Canada Rail Safety S31 Notices and Orders and HRSDC Directions including ensuring response by deadlines
  • Ensure accuracy of reporting of accidents and incidents to the Transportation Safety Board including monthly and annual reconciliation of CN and TSB numbers
  • Work with CN Law department to develop CN strategy for negotiated cost sharing negotiations involving grade separations, road and utility crossings and fencing. Prepare technical and legal arguments to support CN’s position in legal cost apportionment disputes administered by Canadian Transportation Agency
  • University degree in fields such as business management, public affairs, and government affairs is preferred. (terminology maybe different in the US)
  • 3 to 5 years Railroading experience
  • Excellent Microsoft tools knowledge (ex. Excel, Word)
  • Thorough knowledge of CN network and operations as well as Canadian and US regulatory acts, general orders, regulations, rules, guidelines, internal policies and processes concerning CN network and operations
  • The ability to juggle multiple projects and meet deadlines, as well as strong analytical, organizational and process management skills and problem solving abilities needed
  • Sound negotiating skills and proficiency in risk analysis
  • Ability to establish and maintain good working relationships with both internal clients and regulatory agencies, to organize and conduct effective meetings and make presentations to a variety of audiences
  • Initiative, sound judgement and willingness to accept responsibility with a minimum of direction
40

Senior Manager Regulatory Affairs Category Resume Examples & Samples

  • Acts as a Business Partner and provides regulatory advice across sub-Category/significant portfolio on all aspects of drug/cosmetic/devices/foods and supplements (dependent on category) development and regulatory requirements, both current and future
  • Provides regulatory direction for a sub-category/significant portfolio of products. Develops novel regulatory strategies and influences approaches in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams
  • Communicates influences and negotiates effectively with cross-functional internal and external groups at all levels
  • May lead an efficient and well motivated small team; including effective people development
  • Ensure appropriate prioritization and resourcing of projects and delivery of high quality regulatory files to agreed timelines
  • Leads non-product related activities, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage
  • Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines. May act as GSK representative to external groups for specific topics (e.g. AESGP, Cosmetics Europe)
  • Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Copy Review Committee
  • In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc with supply chain and technical excellence Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to
41

Senior Manager, Regulatory Affairs CMC Resume Examples & Samples

  • Regulatory coverage and oversight in all CMC submissions (including clinical trial, marketing and post-marketing applications, routine reports/renewals) and ensure that submissions comply with applicable global regulatory requirements as well as company policies and procedures, with the goal of obtaining the earliest possible product approvals
  • Maintain up-to-date knowledge of regional and global regulatory CMC requirements, analyze current trends and anticipate changes in the Regulatory requirements to adjust CMC strategic plans accordingly
  • Write and review technical documents for submissions and recommend changes as appropriate to ensure approval and/or compliance with existing regulatory approvals
  • Provide regulatory assessments of manufacturing changes within the change control system and filing strategy guidance to Technical Operations and Quality department, including supporting preparation for facility inspections of vendor sites by health authorities when necessary
  • Contribute to the development and implementation of short and long-term regulatory strategies for assigned projects and programs
  • Manage relationships with key stakeholders in technical Operations and Quality and across Regulatory Affairs to provide CMC regulatory support in achieving strategic objectives
  • Work effectively with Regulatory colleagues and stakeholders in addressing GMP issues
  • Create and maintain Regulatory CMC development plans that are aligned with product development plans
  • Initiate local process improvement and contribute to local and/or global process improvements which have significant impact for the Regulatory Affairs Department or other departments
  • The position is responsible for handling multiple projects with competing priorities. May involve up to 10% travel
  • BS in relevant scientific discipline
  • Minimum of 5 years of experience in Regulatory CMC in pharmaceutical industry
  • An advanced degree in relevant scientific discipline is desirable, certification in Regulatory Affairs is a plus
  • Previous experience working in a fast paced environment on multiple product lines a plus
  • Solid understanding of FDA regulations and GMPs requirements on drugs and devices in both development and commercial stage products
  • Good expertise on Regulatory CMC, exposure to international Regulatory CMC is a plus
  • Experience in regulatory assessments of post-marketing manufacturing changes and in preparing technical portion of INDs, NDAs, amendments and supplements
  • Strong organizational and program management skills to maintain high level productivity, innovation and priority setting, completing assignments on time and on budget
  • Strong problem solving and diplomacy skills required
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
42

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Represent regulatory affairs on product development and commercialization teams related to transcatheter mitral valve replacement programs
  • Additional Responsibilities will include
  • Exercise independent judgement in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents
  • Exercise judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Ability to travel 25 %
43

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Prepare and manage annual budgets
  • Assist in regulatory due diligence and acquisition transfer activities
  • Manage and execute pre-approval compliance activities
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Monitor and submit applicable reports and responses to regulatory authorities
  • Ensure compliance with product post-marketing approval requirements
  • Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance
  • Communicate regulatory agency/industry positions to internal stakeholders
  • Conduct technical meetings with regulatory advisory committees and government agencies
  • Support and lead assigned improvement activities
  • Notify, consult or brief legal counsel when appropriate
  • Must have demonstrated extensive working knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices
  • Working knowledge of statistics and electronic documentation and information systems
  • Advanced Degrees preferred
  • Advanced regulatory affairs training – MS, RAC or other professional certification
44

Senior Manager, Regulatory Affairs Global CMC Resume Examples & Samples

  • Planning and co-ordination of the writing and reviewing for Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents)
  • Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late and early stage development programs, under the supervision of GRA-CMC leadership
  • Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to the a multi-disciplinary team
  • Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met
  • Act as regulatory CMC representative at meetings with business partners and regulatory agencies for CMC related issues
  • Monitor Global CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines
  • Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products
  • Verify electronic publishing of regulatory submissions
  • Identify & support continuous improvement opportunities for the GRA-CMC team and the broader GRA team
  • Ensure compliance with company policies, procedures and training expectations
  • Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions
  • Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs)
  • Demonstrated understanding of FDA, EMA and ICH guidelines
  • BSc/BA with a minimum of five years of regulatory CMC experience
45

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Define and execute RA strategies for Europe for pre-approval and post-approval clinical studies and EU commercialization
  • Provide subject matter expertise and/or leadership to TMTT RA organization on European Regulatory requirements
  • Deliver project/change management expertise, strategic planning, and implementation support for key TMTT RA organizational initiative
  • Drive continuous improvement & innovation agenda within the TMTT EU RA function
  • Responsible for following regulatory activities on European basis and advising the relevant Edwards stakeholders
  • Management of registration files submission to National Competent Authorities
  • Participation in different European TMTT Projects providing RA expertise and leadership
  • Local management of ‘product holds’ and field corrective actions
  • RA coordination of new TMTT product launches
  • Advanced Degree or country equivalent in science-related field. Higher degree/PhD will be an advantage
  • Minimum 10+ years in medical device and pharmaceutical industry with increasing levels of expertise/experience
  • Established understanding of registration processes and their inter-dependencies and a demonstrable track record of driving regulatory strategic and operational excellence
  • Expert knowledge of regulations, current industry practices, and strong experience with interpretation and application of regulatory guidelines pertinent to a diverse drug/device portfolio
  • Established credibility with regulatory authorities and other external stakeholders and understanding and translation of regulatory trends into actionable opportunities
  • Required language skills: German, English, additional language a plus
46

Senior Manager, Regulatory Affairs Operations Resume Examples & Samples

  • Participate in the Regulatory Operations Submissions Management Team for Branded Products
  • Ensure all publishing and submissions are undertaken effectively in compliance with timeline requirements
  • Assist in developing strategy for use of electronic document management software (EDMS) within Regulatory and all applicable departments, direct administration of the EDMS, address user requirements and upgrades for the system. Serve as primary point-of-contact
  • Work with Manager, Publishing Group to provide timelines to Project Teams/Regulatory contact regarding submission timelines
  • Maintain current working knowledge of FDA and other global regulatory requirements
  • Work with vendors and various departments on multiple software projects, including new installation and upgrades, serving as a point-of-contact
  • Participate in project team meetings updating status of Regulatory Operations activities, represent the company’s Regulatory Operations group in internal and external development project meetings and contribute to the establishment of regulatory strategies for new products and processes
  • Assist in managing expenditures related to approved contracts
  • Display leadership to staff internal and external to the department
  • Assist in providing regulatory advice and interpretation of submission regulations and guidance to Regulatory Affairs staff and team members
  • Develop and implement SOPs and/or work instructions
  • At least 5 years of experience in Regulatory Affairs, with at least 2 years of experience in Regulatory Operations
  • Managerial experience preferred
  • Knowledge of IT systems and electronic submission requirements and processes for FDA and other global health agencies, for pharmaceuticals, biologics, and medical devices
  • Detailed oriented with a high degree of organizational skills and be able to handle confidential materials. Very strong focus on highest quality
  • Possess very strong PC computer skills
  • Able to accomplish work independently and as part of a team
  • Able to set and meet deadlines
  • Able to take a project from start to finish while working in a constantly changing environment
  • Handle routine details and unexpected changes without losing focus on projects; determine task priority and ensure deadlines are met
  • Team player as demonstrated by good communication/collaboration skills
  • Strong interpersonal skills, including the ability to remain calm, professional, diplomatic, and positive
  • Exercise confidentiality
  • Positive attitude and ability to establish and maintain positive working relationships
47

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Responsible for providing the regulatory considerations and strategies for product prototype development, proof-of-concept activities, partnership options and vendor due diligence
  • Develop, implement, communicate, and maintain regional regulatory plans for TDI/DH (Technology Innovation/Digital Health) initiatives/ projects
  • Perform device determinations for TDI/DH programs as needed
  • Provide support with review of external communications with hospitals, clinics and academic innovation centers as well as contracts, terms and conditions from a regulatory perspective
  • Support TDI/DH technology & software development (including co-development and supplier management) efforts by providing regulatory guidance
  • Deliver ongoing device education and training to TDI/DH colleagues pertaining to innovation
  • Assist in training Amgen Affiliates with respect to regulatory requirements of developing TDI/DH products
  • Facilitate communication of changes in Regulations, Standards, and Policy which are likely to impact TDI/DH activities
  • Represent the EU Tech Hub/Amgen at external events
  • Responsible for developing and maintaining an overall EU process map to bring digital products to market
  • Collaborate with Device Regulatory International personnel who perform EU based (legal manufacturer) registrations
  • Help identify responsible quality contact as needed for project specific needs as well as help identify responsible legal contact as needed
  • 5+ years experience in EU device regulatory matters
  • Some regulatory experience in drug regulatory matters
  • Multi-sectoral awareness/exposure a bonus
  • Regulatory Device and Design Control experience
  • Software development in the healthcare sector
  • Experience working in cross-functional matrix organization
48

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • Representing the region
  • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
  • Regulatory knowledge in national regulations
  • Experience with national legislation and regulations relating to medicinal products
  • Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
  • Understanding of drug development
49

Senior Manager, Regulatory Affairs Resume Examples & Samples

  • In support of Merial strategic objectives and in alignment with Business Operations, Industrial Operations, CMC, and R&D, responsible for the defense and maintenance of FDA-approved products
  • Ensure compliance of pharmaceutical products throughout the lifecycle in close collaboration with Business Operations, R&D, CMC, Quality Assurance, and other departments as appropriate
  • Provide regulatory assessments for proposed business and manufacturing changes related to approved pharmaceutical products in compliance with FDA guidelines
  • Define U.S. Regulatory filing strategies of assigned projects regarding approved products and assigned development projects This includes coordinating activities and defining timing of submission and approval in order to have regulatory agreement, as required, before implementation
  • Prepare regulatory submissions for post-approval activities related to FDA-approved products as well as assigned development projects
  • Prepare labels, package inserts, etc. based on applicable regulations and approved platform label, in cooperation with Business Operations and Supply Chain
  • Serves as regulatory liaison for assigned projects
  • Define regulatory requirements for projects, as assigned, for incorporation into Development Plans for pharmaceutical projects. Set working priorities within the team and communicate them routinely
  • Serve as a member of interdepartmental project/core teams providing regulatory expertise for assigned projects during the development, registration, and post-approval extension phases of a project
  • Principle contact point for Business Operations, R&D, and Industrial Operations regarding change control (ILPM) and strategic issues related to FDA-approved products
  • Promote functional excellence with the goal to foster innovation, optimize time-to-market and reduce project and portfolio risks
  • Serves as a member of interdepartmental working groups providing regulatory expertise for assigned projects or segments of projects related to the supplements or maintenance of approved products
  • Provide technical regulatory support to the RA International team for assigned products
  • Maintains an awareness of regulatory issues and current possible developments in assigned areas
  • Participate in trade association activities as assigned
50

Senior Manager Regulatory Affairs Resume Examples & Samples

  • Prepare US (510{k), PMA, IDE) submissions and technical files
  • Review and approve labeling and promotional materials
  • Develop and recommend regulatory strategies
  • Assist in the review and policies and procedures
  • Interact with the FDA and other regulatory agencies
  • Provide coaching to regulatory specialists
51

Senior Manager, Regulatory Affairs, CMC Resume Examples & Samples

  • Author regulatory content, provide regulatory CMC content guidance, and review all regulatory CMC submissions (Module 3, Module 2.3 and Module 1) such as IND amendments, Meeting Requests/Meeting Packages, NDA, sNDA, MAA and Variations, as needed, for conformance with established requirements
  • Ensures CMC project team colleagues and key stakeholders are apprised of risks that may impact CMC regulatory success, exercising sound judgments and communicating in a professional and timely manner
  • Evaluates change controls for regulatory impact and filing requirements
  • Conduct CMC regulatory due diligence reviews for potential new product opportunities
  • Grow corporate, project and industry knowledge. Analyze and communicate current CMC Regulatory guidance and regulations, as well as industry and regulatory agency best practices and trend to senior management and other departmental personnel
52

Senior Manager Regulatory Affairs, DEA Resume Examples & Samples

  • Establish and lead DEA inspection team, ensure related activities such as the inspection preparation room are managed effectively and efficiently, appropriately delegate inspection related activities to direct reports or partner department staff
  • Ensure staff involved with DEA inspections are trained and records retained appropriately
  • Manage daily activities related to the DEA Corporate Compliance Program and State Licensing compliance such as, but not limited to, theft/loss investigations and reporting, suspicious order monitoring, import/export records, and quotas
  • Monitor regulatory environment related to DEA and State Licensing directly, with assistance from direct reports, and consultants
  • Contact DEA or outside consultants to resolve regulatory issues and negotiate directly as required
  • Ensure regulatory files and data systems are maintained in compliance with internal SOPs
  • Represent regulatory affairs in project meetings and provide regulatory commitments as required
  • Communicate and collaborate with senior management in all areas of the company
  • Support a continuous improvement environment and develop staff to execute continuous improvement projects
  • Provide oversight for RA processes and systems
  • Hire, train, coach/mentor and evaluate performance of direct reports
  • Assign, balance and prioritize workloads of direct reports
  • Ensure quality of all agency submissions and communications
  • Projects as assigned by management
  • Supervises non-exempt and/or exempt direct reports
  • Must possess advanced analytical skills and the ability to identify and apply DEA and State Licensing policies and general regulations to specific products or projects and create new policies as required
  • Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for stakeholders inside and outside of Regulatory Affairs
  • Advanced verbal and written presentation and communication skills are necessary
  • The ability to effectively lead project teams is required
  • Advanced knowledge of scientific, regulatory, DEA, State Licensing and legal terminology is necessary
  • These skills are normally acquired through possession of a Bachelor Degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined with 8-10 years of experience in the health care or pharmaceutical industry and 7+ years of hands on experience in DEA and State Licensing activities
  • 7 or more years of experience in direct supervision
53

Senior Manager Regulatory Affairs Resume Examples & Samples

  • University Degree (Bachelor of Science or equivalent scientific discipline)
  • Minimum of 8 years of experience in regulatory affairs, preferably in industry with some focus on natural health products
  • Strong Knowledge of Canadian Regulations
  • Team player who thrives in a fast-paced environment with proven ability to manage multiple priorities
  • Experience in leadership management an asset
  • Foresees and clearly communicates potential problems/risks and offers creative, workable solutions
  • English advanced level, both oral and written. French and/or Mandarin a strong asset
  • Strategic thinker adept at working cross-functionally to achieve goals in a timely manner
  • Effective in an environment requiring independent initiative with multiple deadlines and changing priorities