What do Regulatory Counsels do at CDER?
The duties of a Regulatory Counsel at CDER differ by office. Opportunities may include:
- Applying knowledge of the drug regulation process to resolve a broad range of regulatory, scientific, and technical issues concerning the application of the Food, Drug, and Cosmetic Act; Public Health Service Act; and other applicable laws, regulations, guidances, and policies.
- Providing expert guidance, sensitive to both the technical and regulatory issues, in preparation of correspondence and other documents that interpret the applicable laws, regulations, guidances, and policies. Correspondence may include responses to letters and inquiries from the pharmaceutical industry, Congress, citizens, and other stakeholders.
- Evaluating regulations, guidances, and polices to ensure they are supported by adequate scientific and medical analysis. Working with scientific, regulatory, and legal experts to develop and draft proposals to revise existing regulations, guidances, and policies. Developing and implementing new regulations, guidances, and policies, which are often broad in scope and generally affect either the entire industry or a significant sector of the regulated industry.
- Identifying and evaluating the appropriateness of compliance and/or other actions.
- Supervising major studies and projects concerned with the analysis and evaluation of regulatory process issues of national scope and significance.
Note: Please review each grade announcement for a full list of job duties.
How can I find a Regulatory Counsel position at CDER?
Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.
- Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 0301 - Miscellaneous Administration And Program.
- Visit We Are Hiring | FDA to find a current listing of opportunities utilizing the FDA 21st Century Cures Act Hiring Authority.
Where can I learn more about careers at the FDA?
For general information on working at the FDA and additional employment opportunities, visit: Jobs and Training at FDA.