Regulatory Affairs Manager

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AVG. SALARY

$130,800

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EDUCATION

Bachelor's degree

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JOB OUTLOOK

Stable

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:

  • Develops and reviews regulatory strategies, development plans, and implementation plans for the preparation and submission of new products.
  • Reviews all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Directs the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Investigates product complaints and prepares documentation and submissions to appropriate regulatory agencies as necessary.
  • Provides responses to regulatory agencies regarding product information or issues.
  • Represents organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Provides regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Manages activities such as audits, regulatory agency inspections, or product recalls.
  • Communicates regulatory information to multiple departments and ensures that information is interpreted correctly.
  • Maintains current knowledge of relevant regulations, including proposed and final rules.

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:

  • CMC Director (Chemistry, Manufacturing, and Controls Director)
  • Compliance Director
  • Global RA Director (Global Regulatory Affairs Director)
  • Global RA Manager (Global Regulatory Affairs Manager)
  • RA Director (Regulatory Affairs Director)
  • RA Manager (Regulatory Affairs Manager)
  • RA QA Director (Regulatory Affairs Quality Assurance Director)
  • RA VP (Regulatory Affairs Vice President)
  • Vaccine RA Director (Vaccine Regulatory Affairs Director)
  • Regulatory Director