Regulatory Scientific Reviewer (Regulatory Specialist)
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 1, Band B (GS 12 equivalent).
Major duties
Coordinates with multidisciplinary teams and provides technical guidance on moderately complex regulatory matters. Conducts comprehensive evaluations of complex regulatory submissions, including detailed analysis of manufacturing practices, quality systems, clinical data and labeling for accuracy and completeness. Applies deep scientific expertise to interpret complex data and make authoritative recommendations regarding product approval or regulatory action that are typically accepted by supervisory officials. Establishes scientific principles and regulatory frameworks to assess data submitted by manufacturers and sponsors, determining compliance with FDA standards and regulatory requirements. Provides authoritative input on regulatory decisions within their area of expertise and increasingly on related matters requiring cross disciplinary knowledge. Represents the Office/Center in professional forums, serves as a technical expert on complex review teams, and contributes to collaborative activities with internal and external stakeholders providing authoritative scientific perspectives.
What you need to qualify
In order to qualify for the Regulatory Scientific Reviewer (Regulatory Specialist) position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/21/2026: Minimal Qualifications Requirements for the Regulatory Scientific Reviewer AD-0696-00 Basic Qualification Requirements: A bachelor's or graduate/higher level degree in quality assurance or a related degree in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer product reviewer work. AND/OR Professional experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS BAND B, RC-0696. Have a bachelor's degree and have 3 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards. OR Have a master's degree and have 2 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards. OR Have a Doctorate and/or J.D. degree and have 1 year of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards. OR Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards. OR Have 5 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
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