Regulatory Counsel
What you'd do
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 C.
Major duties
Drafts or critically reviews policy documents and program proposals and decisions on these products, including regulations, citizen petition responses, proposed legislation, and policy statements. Reviews, summarizes, and drafts responses to all public comments received on proposed regulations, recommends adoption or rejection of counter-proposals contained in comments and objections, and drafts final regulations. Prepares replies to correspondence from the regulated community, Congress, and other interested persons on issues that are industry-wide or have broad health implications and that concern precedent-setting interpretations of laws governing FDA policy Ensures that regulations and policies developed in the assigned areas are consistent with the statutory requirements and existing policy. Serves as a regulatory resource in the statutes, regulations, policies, procedures, and implications relevant to the issuance of FDA regulations. Petitions responses and conducts thorough analyses of complex regulatory and policy issues and provides advice to staff in CDER in carrying out its regulatory mission.
What you need to qualify
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 07/24/2026: Basic Qualification Requirements: You must have a law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution. OR You must have comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze regulations and policies for regulated products. AND RELEVANT YEARS OF EXPERIENCE: IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and also have four (4) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to FDA-regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of FDA-regulated products. OR Have a master's degree and also have three (3) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. OR Have a doctorate or a JD degree and also have one (1) year of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. OR Have a MD/DO/DDS/DPM/DVM degree. OR Have six (6) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
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