Description of Duties at GS-13 level:
- Resolves a broad range of regulatory, scientific, and technical issues concerning the application of the Food, Drug, and Cosmetic Act.
- Applies knowledge of the drug approval process, and interprets the Federal Food, Drug, and Cosmetic Act and other pertinent and applicable laws and regulations.
- Works with reviewers to determine the extent of regulatory authority in specific situations.
- Develops and drafts proposals for revision of existing regulations and policy statements.
- Provides expert guidance, sensitive to both the technical and regulatory issues, in preparation of correspondence that interprets the regulation.
- Provides regulatory expertise in evaluating and developing responses to letters from the pharmaceutical industry.
- Identifies and evaluates the appropriateness of potential cases for enforcement action.
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 to regulatory issues affecting a program/agency; and drafting regulatory documents such as regulatory opinions and regulatory memoranda for review.
Grade (Salary) Level
Federal General Schedule (GS) grade levels at which regulatory counsel positions are commonly filled are: