How do they match: 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.

  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

  • Establish organizational guidelines or policies.
  • Communicate with government agencies.