Regulatory Scientific Reviewer (Pharmacologist)

Regulatory Scientific Reviewer (Pharmacologist)

Department: Department of Health and Human Services

Location(s): Silver Spring, Maryland

Salary Range: $121785 - $169583 Per Year

Job Summary: 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).

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. Advises 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.

Qualifications: In order to qualify for the Regulatory Scientific Reviewer (Pharmacologist) position which falls under the 0405 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/20/2026: Minimum Qualification Requirements: 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 history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques. 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 and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques. Have a Master's degree and also have 3 years of comparable experience analyzing and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques. Have a Doctorate/or JD degree and also have 1 year of comparable experience analyzing and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques. Have a MD/DO/DDS/DPM/DVM degree. Have six (6) years of comparable experience analyzing and advising on the history, sources, physical and chemical properties, biochemical, toxic and physiological effects, mechanisms of action, absorption, distribution, metabolism, biotransformation and excretion, and therapeutic and other uses of drugs as well as modern pharmacological techniques. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Minimum Qualifications.

How to Apply: In accordance with Executive Order 14170, applicants are encouraged to respond to the four short, free-response, essay questions in the questionnaire. Answers to these questions are optional and will not be scored or rated. Your answers will be reviewed by the hiring manager and agency leadership if you are referred for selection consideration. You will be asked to certify that your responses are written in your own words and that you did not use a consultant or artificial intelligence (AI) tool (such as ChatGPT or Copilot). Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. To apply for positions with the Food & Drug Administration, you must have a https://secure.login.gov/ account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 03/20/2026. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://help.usajobs.gov/how-to. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Contact us at: USAJOBS - Contact us FDA's Applicant Help Desk is not able to support USAJOBS-related issues. The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://appsupport-usastaffing.opm.gov/hc/en-us. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail ERIC@fda.hhs.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12900049 so that we may assist you faster.

Application Deadline: 2026-03-20