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Regulatory Affairs Specialist

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Bachelor's degree or higher +

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What They Do

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 Public Management and Administration pathway.

A person in this career:

  • Coordinates, prepares, or reviews regulatory submissions for domestic or international projects.
  • Provides technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Reviews product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • 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.
  • Advises project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Prepares or maintains technical files as necessary to obtain and sustain product approval.
  • 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.

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 Specialist (RA Specialist)
  • Regulatory Affairs Associate (RA Associate)
  • Regulatory Specialist
  • Regulatory Affairs Consultant (RA Consultant)