- Performing regulatory reviews of action packages for enforcement actions, including Warning Letters and seizure and injunction referrals.
- Developing and revising policies, programs, regulations, and guidance documents involving complex matters affecting drug compliance.
- Drafting or reviewing proposals for new regulations and policy statements.
- Providing senior-level 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.
GS-14: Have at least one full year of specialized experience, equivalent to the GS-13 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.
- Developing regulations, guidelines, policy, or programs that affect the regulation of drugs.