Regulatory Scientific Reviewer

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 on Title 21 Pay Table 1, Band B/C FPBL C (GS-12/13 equivalent).

In order to qualify for the Regulatory Scientific Reviewer position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/20/2026: Basic Qualification Requirements: You must have a Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position.

This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.

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 - Minimum Experience and/or Education Requirements: A.

Have a Bachelor's degree and also have 3 years of comparable experience conducting regulatory reviews and evaluations of significant scope and complexity; applying scientific principles and regulatory frameworks to assess data submitted by manufacturers and sponsors; and interpreting complex data and making recommendations regarding product approval or regulatory action.

B.

Have a Master's degree and also have 2 years of comparable experience conducting regulatory reviews and evaluations of significant scope and complexity; applying scientific principles and regulatory frameworks to assess data submitted by manufacturers and sponsors; and interpreting complex data and making recommendations regarding product approval or regulatory action.

C.

Have a Doctorate/or JD degree and also have 1 year of comparable experience conducting regulatory reviews and evaluations of significant scope and complexity; applying scientific principles and regulatory frameworks to assess data submitted by manufacturers and sponsors; and interpreting complex data and making recommendations regarding product approval or regulatory action.

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

Have a Bachelor's degree and also have 4 years of comparable experience analyzing complex data and guidelines or criteria for scientific review and approval for a class of products; Advising on research initiatives, and product-specific protocols; and identifying risks, gaps, trends, and review or coordination of review of important precedent setting scientific issues.

B.

Have a Master's degree and also have 3 years of comparable experience analyzing complex data and guidelines or criteria for scientific review and approval for a class of products; Advising on research initiatives, and product-specific protocols; and identifying risks, gaps, trends, and review or coordination of review of important precedent setting scientific issues.

C.

Have a Doctorate/or JD degree and also have 1 year of comparable experience analyzing complex data and guidelines or criteria for scientific review and approval for a class of products; Advising on research initiatives, and product-specific protocols; and identifying risks, gaps, trends, and review or coordination of review of important precedent setting scientific issues.

D. Have a MD/DO/DDS/DPM/DVM degree NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Major Duties:

The regulatory scientific reviewer plans and carries out the assignments, resolves most technical conflicts, and leads multidisciplinary teams to address high-impact, controversial, or precedent-setting issues within their designated area of expertise.

The reviewer coordinates assignments with internal FDA stakeholders and external parties, ensuring seamless integration with broader Agency regulatory programs.

When warranted, it assumes responsibility for a team effort to resolve complex or regulatory significance of issues and problems relating to the area of assignment.

The scientist's responsibility includes authoritative regulatory review, and his/her expertise is relied upon and utilized throughout the Office's/Center's functional areas, e.g., research, review, regulatory functions, etc.

This may include advising on area specific research, product specific inspections, or product release responsibilities.

Coordinates the assignment with interested parties internal and external to the Agency and integrates it into the broader regulatory programs of the FDA.

Assures that legal and policy considerations are adequately addressed, as well as purely technical matters. Advises on specialized research initiatives, and product-specific protocols.

As the subject matter expert (SME), the regulatory reviewer has deep scientific or technical expertise in scientific discipline.

The scientist is an Agency spokesperson and authoritative source of information and advice on matters related to the assigned area of responsibility.

This might be manifested by activities such as the following, within the scientist's area of expertise: - Analyze complex data and guidelines or criteria for scientific review and approval for a class of products.

- Identify risks, gaps, trends, and review or coordination of review of important precedent setting scientific issues which establish Agency policy for subsequent reviews of similar products.

- Mentor junior reviewers. - May influence policy interpretation or review standards. - Make recommendations that go to the supervisor, team leads, branch chief etc. for directors' concurrence.