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Regulatory Affairs Specialist

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Bachelor's degree or higher +

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What They Do

About This Career

Coordinates and documents internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

This career is part of the Government and Public Administration cluster Governance pathway.

A person in this career:

  • Coordinates efforts associated with the preparation of regulatory documents or submissions.
  • Prepares or directs the preparation of additional information or responses as requested by regulatory agencies.
  • Communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Coordinates, prepares, or reviews regulatory submissions for domestic or international projects.
  • Prepares or maintains technical files as necessary to obtain and sustain product approval.
  • Interprets regulatory rules or rule changes and ensures that they are communicated through corporate policies and procedures.
  • Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Coordinates recall or market withdrawal activities as necessary.
  • Advises project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Reviews adverse drug reactions and files all related reports in accordance with regulatory agency guidelines.

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

  • Regular working hours and limited travel

Specialty and Similar Careers

Careers that are more detailed or close to this career:

  • Drug Regulatory Affairs Specialist
  • Regulatory Services Consultant
  • Regulatory Submissions Associate
  • Regulatory Affairs Analyst (RA Analyst)
  • Regulatory Engineer
  • Regulatory Affairs Strategist (RA Strategist)
  • Regulatory Affairs Associate (RA Associate)
  • Regulatory Specialist
  • Regulatory Affairs Consultant (RA Consultant)


  • 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