Regulatory Scientist
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 A. (GS 11 equivalent).
Major duties
Applies scientific knowledge and regulatory understanding to assess data submitted by manufacturers and other stakeholders. Evaluates regulatory submissions, including comprehensive review of manufacturing information, quality date, and labeling materials for compliance with applicable regulations using established methodologies and standards. Contributes to the preparation of regulatory communications with appropriate technical depth and may serve as a technical resource on review teams. Provides analyses and recommendations for high-priority consumer complaints and product complaints related to nutrition, toxic elements, allergens, foodborne illness, dietary supplements, infant formula, etc. Manages and coordinates HFP-related complaints received from consumers, industry, medical professionals, State, Local, Tribal and Territorial (SLTT) authorities, and other Federal agencies and public health partners
What you need to qualify
In order to qualify for the Regulatory Scientist position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2026: Minimal Qualifications Requirements for the Regulatory Scientist RC-696-00 Basic Qualification Requirements: . Education: A bachelor's degree or higher in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field. The degree must be from an accredited program or institution. -OR- Have 4 years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates. Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity. Product development, process development, scale-up, or commercial manufacturing. Sterility assurance and microbiological controls. IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS FOR THE BAND A. 1. Have a bachelor's degree and also have two (2) years of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution. 2. Have a master's degree and also have one (1) years of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution. 3. Have a Doctorate and/or J.D. degree and zero (0) year of comparable experience 4.. Have a MD, DO, DDS, DPM, or DVM degree. 5. Possess four (4) years of comparable experience in conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
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