Staff Director (Supervisory Regulatory Counsel)

Full Job Description

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624.

The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

This position is being recruited based on the Title 21 Pay Table 2, Band E.

In order to qualify for the Staff Director (Supervisory Regulatory Counsel) position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/06/2026: Minimal Qualifications Requirements for the Regulatory Counsel, AD-0301-00 Education: A law degree, specifically a LL.M.

or J.D. The degree must be from an accredited program or institution.

OR Comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze regulations and policies for regulated products.

In addition, to qualify for the Band E level, applicants must meet the qualification requirements below. Law degree, specifically a LL.M. or J.D.

degree and also have 3 years of relevant experience in handling regulatory issues, relevant experience could include, but is not limited to experience in a law firm, FDA-regulated industry, or government or non-governmental setting, such as by writing or commenting on regulations; preparing or responding to petitions; drafting or commenting on legislation; or providing advice on the interpretations of laws, regulations, and policies.

OR 9 years of relevant experience in handling regulatory issues, relevant experience could include, but is not limited to experience in a law firm, FDA-regulated industry, or government or non-governmental setting, such as by writing or commenting on regulations; preparing or responding to petitions; drafting or commenting on legislation; or providing advice on the interpretations of laws, regulations, and policies.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Major Duties:

Advising HFP officials on regulatory and policy issues and coordinates with peer across FDA as needed on recurring or broad regulatory matters.

Overseeing the development of regulations, Federal Register notices, and guidance documents.

Overseeing development of responses to citizen petitions and petitions for reconsideration or stay of action.

Overseeing preparation of materials related to delegations of authority, legislation, and other administrative documents. Establishing program goals and objectives for the staff.

Leading/serving as a member of task forces and workgroups called to consider problems or direction in the area of regulatory policy.

Meeting with representatives of the regulated industry regarding particular problems in the area of regulatory expertise.

Maintaining continuing liaison with other organizations within HFP, FDA, State and local governments, foreign governments, and other regulated community.