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 D.

(GS-14 equivalent) In order to qualify for the Regulatory Counsel position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 04/21/2026: 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 2 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 such as interpreting or drafting laws, regulations, or policies related to foods, dietary supplements, cosmetics or other products subject to federal regulations.

OR 7 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 interpreting or drafting laws, regulations, or policies related to foods, dietary supplements, cosmetics or other products subject to federal regulations.

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

Develops, evaluates, and reviews regulatory products, such as regulations, guidance documents, notices, and citizen petition responses, involving sensitive, complex, and high-priority matters relating to human foods, including food safety, nutrition, labeling, and other issues related to infant formula and medical foods.

Supports and coordinates development of new polices, guidance, and/or regulations on human foods and dietary supplements.

Coordinates and translates critical input from such experts to develop and review policy and regulatory recommendations and documents (e.g., regulations, guidance, other regulatory policy documents) for senior HFP and FDA leadership.

Provides authoritative advice and mentoring to Regulatory Counsels and HFP scientific experts on the development and review of critical regulatory policy documents and on the implementation of complex legislation.

Initiates, coordinates, monitors, and reviews the development and implementation of a diverse portfolio of policies, national and international standards, procedures (including rulemaking initiatives, guidance for industry and FDA staff, international food safety equivalency determinations, and/or internal Program/ Agency procedures) to address food safety and nutrition priorities with national and international impacts.