Regulatory Scientific Reviewer

Regulatory Scientific Reviewer

Department: Department of Health and Human Services

Location(s): Silver Spring, Maryland

Salary Range: $143913 - $197200 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 1, Band D (GS-14 equivalent).

Major Duties:

• The regulatory scientific reviewer provides technical leadership and guidance in an assignment area of major importance to FDA, such as a product class, a process, or a scientific discipline. This involves responsibility for setting specific objectives, determining the approach, planning, scheduling, and carrying out all work associated with the assignment. As appropriate, assumes responsibility for a team effort to resolve a particularly complex, controversial, or far-reaching problem 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. As appropriate, may coordinate hearings required in connection with the assignment. As a technical expert, 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: Development of guidelines or criteria for scientific review and approval for a class of products; Authoritative review or coordination of review of important precedent setting scientific issues which establish Agency policy for subsequent reviews of similar products; Publication of scientific articles within the scientist's area of expertise in the open literature; Developing new rules concerning a class of products, preparing these rules for publication in the Federal Register and serving as the Agency contact point on all matters related to such rules; Representing and speaking for the Agency at national professional conferences; Invitations to address technical societies or trade associations; Assignment to work with national/international health agencies; or Representing the Agency in collaborative national or international activities.

Qualifications: 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. A. Have a Bachelor's degree and also have 5 years of comparable experience developing guidelines or criteria for scientific review and approval for a class of products; reviewing or coordinating of review of important precedent setting scientific issues; developing new rules concerning a class of products and preparing these rules for publication in the Federal Register; setting specific objectives, determining the approach, planning and scheduling; and representing the organization in professional forums. B. Have a Master's degree and also have 4 years of experience developing guidelines or criteria for scientific review and approval for a class of products; reviewing or coordinating of review of important precedent setting scientific issues; developing new rules concerning a class of products and preparing these rules for publication in the Federal Register; setting specific objectives, determining the approach, planning and scheduling; and representing the organization in professional forums. C. Have a Doctorate/or JD degree and also have 2 years of experience developing guidelines or criteria for scientific review and approval for a class of products; reviewing or coordinating of review of important precedent setting scientific issues; developing new rules concerning a class of products and preparing these rules for publication in the Federal Register; setting specific objectives, determining the approach, planning and scheduling; and representing the organization in professional forums.. D. Have a MD/DO/DDS/DPM/DVM Degree and also have 2 years of experience developing guidelines or criteria for scientific review and approval for a class of products; reviewing or coordinating of review of important precedent setting scientific issues; developing new rules concerning a class of products and preparing these rules for publication in the Federal Register; setting specific objectives, determining the approach, planning and scheduling; and representing the organization in professional forums. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic 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) 12899746 so that we may assist you faster.

Application Deadline: 2026-03-20