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Regulatory Affairs Specialists

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

What you’d do

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.

Skills that matter

  • Active Listening
  • Critical Thinking
  • Judgment and Decision Making
  • Reading Comprehension
  • Speaking
  • Writing

How to get there

Considerable preparation: most need a four-year bachelor's degree

Also called

  • RA Associate (Regulatory Affairs Associate)
  • RA Consultant (Regulatory Affairs Consultant)
  • Regulatory Consultant
  • Regulatory Specialist
  • Drug Regulatory Affairs Specialist
  • QA Specialist (Quality Assurance Specialist)

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