Regulatory Affairs Manager  What They Do

Just the Facts

Regulatory Affairs Managers Career Video

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:

  • 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.
  • Provides regulatory guidance to departments or developments project teams regarding design, development, evaluation, or marketing of products.
  • Formulates or implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Communicates regulatory information to multiple departments and ensures that information is interpreted correctly.
  • Manages activities such as audits, regulatory agency inspections, or product recalls.
  • Develops regulatory strategies and implementation plans for the preparation and submission of new products.
  • Provides responses to regulatory agencies regarding product information or issues.
  • Maintains current knowledge of relevant regulations, including proposed and final rules.
  • Investigates product complaints and prepares documentation and submissions to appropriate regulatory agencies as necessary.

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 Vice President (RA VP) --
  • Regulatory Affairs Quality Assurance Director (RA QA Director) --
  • Regulatory Affairs Manager (RA Manager) --
  • Regulatory Affairs Director (RA Director) --
  • Quality Affairs Vice President (Quality Affairs VP) --
  • Global Regulatory Affairs Manager (Global RA Manager) --
  • Global Regulatory Affairs Director (Global RA Director) --
  • Regulatory Vice President (Regulatory VP) --