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  7. Regulatory Counsel (Office of Compliance) GS-301-13
  1. Center for Drug Evaluation and Research

Regulatory Counsel (Office of Compliance) GS-301-13

Regulatory Counsel (Office of Compliance) GS-301-13

Duties:

  • Performing regulatory reviews of action packages for enforcement actions, including Warning Letters and seizure and injunction referrals.
  • Working with the organization to develop and revise policies, programs, regulations, and guidance documents involving complex matters affecting drug compliance.
  • Drafting or reviewing proposals for new regulations and policy statements.
  • Providing expert guidance, sensitive to both the technical and regulatory issues, in preparation of correspondence that interprets the regulation.
  • Informing management and staff about new legislation, new or revised regulations, internal policies and procedures, and trends in the pharmaceutical and health care industries.

QUALIFICATIONS REQUIRED:

GS-13: Have at least one full year of specialized experience, equivalent to the GS-12 grade level or higher in the Federal service, that included:

  • Conducting research, interpreting, and applying statutes and regulations affecting scientific regulatory programs such as food and drug, healthcare, environmental, or other complex technical regulatory programs.
  • Drafting regulatory documents such as regulatory opinions and regulatory memoranda for review