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Regulatory Affairs Manager

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Bachelor's degree

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What They Do

Regulatory Affairs Managers Career Video

About This Career

Plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.

This career is part of the Business Management and Administration cluster General Management pathway.

A person in this career:

  • Provides responses to regulatory agencies regarding product information or issues.
  • Directs the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Reviews all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Develops regulatory strategies and implementation plans for the preparation and submission of new products.
  • Manages activities such as audits, regulatory agency inspections, or product recalls.
  • Formulates or implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Maintains current knowledge of relevant regulations, including proposed and final rules.
  • Reviews materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Communicates regulatory information to multiple departments and ensures that information is interpreted correctly.
  • Provides regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

Working Conditions and Physical Demands

People who do this job report that:

  • You would sit most of the time. There's some walking and standing. You may have to lift and carry things like books, papers or tools weighing 10 lbs. or less.
  • Work in this occupation requires being inside most of the time
  • Work in this occupation involves sitting more than one-third of the time

Working in this career involves (physical activities):

  • Seeing clearly up close
  • Speaking clearly enough to be able to be understood by others
  • Identifying and understanding the speech of another person

Work Hours and Travel

  • Overtime work
  • Weekend work

Specialty and Similar Careers

Careers that are more detailed or close to this career:

  • Regulatory Science Director
  • Regulatory Director
  • Regulatory Affairs Quality Assurance Director (RA QA Director)
  • Regulatory Affairs Director (RA Director)
  • Global Regulatory Affairs Manager (Global RA Manager)
  • Global Regulatory Affairs Director (Global RA Director)


  • Email Support
  • 1-800-GO-TO-XAP (1-800-468-6927)
    From outside the U.S., please call +1 (424) 750-3900
  • North Dakota Career Resource Network
    ndcrn@nd.gov | (701) 328-9733