Regulatory Scientific Reviewer (Toxicologist)

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 (GS-13 equivalent).

In order to qualify for the Regulatory Scientific Reviewer (Toxicologist) position which falls under the 0415 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/20/2026: Basic Qualification Requirements: Applicants must meet the qualifications below: Possess a bachelor's degree or higher in toxicology, pharmacology, environmental sciences, medicinal chemistry, pharmaceutical sciences, or related sciences.

The degree must be from an accredited program or institution. OR Possess an American Board of Toxicology Certification.

OR Possess experience analyzing and advising on the adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure.

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

Have a Bachelor's degree and also have 4 years of comparable experience analyzing advising on the adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure.

Have a Master's degree and also have 3 years of comparable experience analyzing and advising on the adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure.

Have a Doctorate/or JD degree and also have 1 year of comparable experience analyzing and advising on the adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure.

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

Have six (6) years of comparable experience analyzing and advising on the adverse effects of chemical substances and physical agents on living organisms and/or the environment, and the assessment of the probability of their occurrence under specified conditions of use or exposure.

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

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.

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

Assumes responsibility for a team effort to resolve complex or regulatory significance of issues and problems relating to the area of assignment.

Conducts 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.

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

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.