Regulatory Scientific Reviewer (Epidemiologist)

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 C FPL C.

In order to qualify for the Regulatory Scientific Reviewer (Epidemiologist) position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/20/2026: Minimum Qualifications Requirements: A.

Must have a bachelor's degree or higher in epidemiology, medical, economics, statistics, pharmacology, or public health. The degree must be from an accredited program or institution. OR B.

Must have comparable experience conducting epidemiological reviews of sponsor protocols and study reports, planning and executing epidemiological research on FDA-regulated products, and providing expert consultant services through all phases of study development from research question specification and study design selection to data analysis using appropriate statistical techniques and integration of findings into regulatory decision-making processes.

AND IN ADDITION TO MEETING THE MINIMUM REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS.

Band C - Minimum Experience and/or Education Requirements: A.

Have a Bachelor's degree and also have 4 years of comparable experience conducting scientific reviews of regulatory submissions; coordinating with internal and external stakeholders to integrate assignments into broader organizational programs; analyzing technical data and contributing to the development of guidelines for product review and approval; advising on research initiatives, protocols, inspections, and product release; and/or making evidence-based recommendations to senior leadership on matters of regulatory significance.

B.

Have a Master's degree and also have 3 years of comparable experience conducting scientific reviews of regulatory submissions; coordinating with internal and external stakeholders to integrate assignments into broader organizational programs; analyzing technical data and contributing to the development of guidelines for product review and approval; advising on research initiatives, protocols, inspections, and product release; and/or making evidence-based recommendations to senior leadership on matters of regulatory significance.

C.

Have a Doctorate/or JD degree and also have 1 year of comparable experience conducting scientific reviews of regulatory submissions; coordinating with internal and external stakeholders to integrate assignments into broader organizational programs; analyzing technical data and contributing to the development of guidelines for product review and approval; advising on research initiatives, protocols, inspections, and product release; and/or making evidence-based recommendations to senior leadership on matters of regulatory significance.

D. Have a MD/DO/DDS/DPM/DVM degree. E.

Have six (6) years of comparable experience conducting scientific reviews of regulatory submissions; coordinating with internal and external stakeholders to integrate assignments into broader organizational programs; analyzing technical data and contributing to the development of guidelines for product review and approval; advising on research initiatives, protocols, inspections, and product release; and/or making evidence-based recommendations to senior leadership on matters of regulatory significance.

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

Plan, conduct, and oversee complex regulatory scientific reviews within designated area of expertise. Resolve technical conflicts to address high-impact, controversial, or precedent-setting issues.

Coordinate regulatory assignments with internal FDA stakeholders and external parties to ensure seamless integration with broader Agency regulatory programs.

Analyze data and evaluate guidelines and criteria for scientific review and approval of product classes.

Identify risks, gaps, and trends in regulatory science, and coordinate review of precedent-setting issues that establish Agency policy and influence review standards.

Provide authoritative regulatory review and expert consultation on specialized matters including area-specific research, product-specific inspections, and product release responsibilities.

Mentor and provide technical guidance to junior reviewers, sharing deep scientific and technical expertise to build organizational capacity and ensure consistency in regulatory review standards.