U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Jobs and Training at FDA
  4. Jobs at the Center for Drug Evaluation and Research (CDER)
  5. Regulatory Counsel (Office of Compliance) GS-301-13
  1. Jobs at the Center for Drug Evaluation and Research (CDER)

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
Back to Top