Regulatory Scientist

Employment Details This position is being filled under a streamlined hiring authority, Title21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section3072 and the Consolidated Appropriations Act of 2023, Section3624. The selected candidate 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 Title21 Pay Table1, BandA (GS11 equivalent). Qualifications To qualify for the Regulatory Scientist position (0696 occupational series) you must meet the following requirements by 11:59pmEST on 07/14/2026. 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, from an accredited program or institution. Have 4years of comparable regulatory experience or FDA‑regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations, including 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. Minimum Years of Experience Requirements for BandA Have a bachelor's degree and two (2) years of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution. Have a master's degree and one (1) year of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution. Have a Doctorate and/or J.D. degree and zero (0) years of comparable experience. Have a MD, DO, DDS, DPM, or DVM degree. 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. #J-18808-Ljbffr