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.

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: A bachelor's degree or higher in pharmaceutical science, pharmaceutical engineering, pharmacology, chemistry, biology, microbiology, chemical engineering, biochemical engineering, biomedical engineering, pharmacy, biochemistry, molecular biology, physical sciences, life sciences, engineering, mathematics, PharmD, biological sciences, agriculture, natural resource management.

The degree must be from an accredited program or institution.

-OR- Have a minimum of six (6) years of relevant 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:

Duties may include but are not limited to: Formulates recommendations and decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions.

Evaluates the identification and characterization of drug substance's pharmaceutical properties and their impact on the drug products performance, manufacturing, and quality.

Applies a risk and scientific-based approach to evaluate the adequacy of formulation studies to understand the impact of drug substance and excipient attributes on drug product performance.

Evaluates the adequacy of analytical procedures and controls as well as associated sampling plans for quality testing, monitoring, and control.

Identifies and analyzes the role of the manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes.