Regulatory Scientific Reviewer (Pharmaceutical Scientist)

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 1, Band C (GS-13 equivalent).

In order to qualify for the Regulatory Scientific Reviewer (Pharmaceutical Scientist) 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: Bachelor's degree or higher in pharmaceutical science, pharmaceutical engineering, pharmacology, chemistry, biology, microbiology, chemical engineering, biochemical engineering, pharmacy, biochemistry, molecular biology, physical sciences, life sciences, engineering, mathematics, PharmD, biological sciences, agriculture, or natural resource management.

The degree must be from an accredited program or institution.

-OR- Six (6) years of experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals.

The work includes team-based evaluation and assessment of supplements through risk management practices.

AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. 1.

Have a bachelor's degree and also have four (4) years of comparable experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals.

The work includes team-based evaluation and assessment of supplements through risk management practices. 2.

Have a master's degree and also have three (3) years of comparable experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals.

The work includes team-based evaluation and assessment of supplements through risk management practices. 3. Have a Doctorate and/or J.D.

degree and also have one (1) year of comparable experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals.

The work includes team-based evaluation and assessment of supplements through risk management practices. 4. Have a MD, DO, DDS, DPM, or DVM degree. 5.

Have six (6) years of comparable experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals.

The work includes team-based evaluation and assessment of supplements through risk management practices.

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

Analyzing complex data and guidelines or criteria for scientific review and approval for a class of products.

Advising on area specific research, product specific inspections, or product release responsibilities.

Identifying 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.

Advising on specialized research initiatives, and product-specific protocols.