Regulatory Specialist

Regulatory Specialist

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 1, Band C.

Major Duties:

• Conducts reactive post market quality-based assessments of complex facilities and products by identifying, evaluating, and trending quality intelligence, such as post market defect reports, laboratory testing results, and drug amount reporting, to execute response actions that mitigate urgent quality issues and risks associated with pharmaceutical formulation and manufacturing processes. Participates in or leads routine inspections, pre-operational activities, or quality management maturity assessments, as necessary. Performs complex quality surveillance activities to characterize the state of pharmaceutical quality and proactively manage risks affecting product quality and availability through facility and product assessments. Informs risk-based prioritization of quality surveillance assignments, such as sampling and testing, inspections, or investigations. Reviews and evaluates submissions for drug and biologics manufacturing processes and facilities to assess the adequacy of pharmaceutical manufacturing design and understanding, as well as process monitoring, control, and scale-up strategies. For biologics and sterile drug substances, and sterile drug products, this includes product packaging integrity, cross-contamination prevention, microbiology product quality and sterility assurance, and technical product quality microbiology aspects of labeling. Reviews and evaluates inspection and investigation evidence and findings indicating a possible lack of compliance with Agency enforcement laws and regulation, including as they pertain to the pre-approval and pre-license inspection compliance programs, or potential issues with drug manufacturing and product quality. Serves as the regulatory manager/coordinator for an assigned group of drug/biological products or office level program. Activities may include management (coordination, fact-finding, etc.) of applications from investigational stage through marketing application review, and post-marketing quality oversight. Establishes and implements all goals, deadlines, and other metrics specified in the applicable User Fee Act (UFA), laws/statue, regulations, and internal procedures are met for assigned projects. Serves as the primary point-of-contact with regulated industry for all issues related to the status of applications or office level programs.

Qualifications: In order to qualify for the Regulatory Specialist position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/25/2026: Basic Qualification Requirements: A bachelor's degree or higher in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field. The degree must be from an accredited program or institution. -OR- Have 6 years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates. Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity. Product development, process development, scale-up, or commercial manufacturing. Sterility assurance and microbiological controls. 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 in the following: Comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: -Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates.- Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.- Product development, process development, scale-up, or commercial manufacturing.- Sterility assurance and microbiological controls. 2. Have a master's degree and also have three (3) years of comparable experience in the following: Comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: -Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates.- Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.- Product development, process development, scale-up, or commercial manufacturing.- Sterility assurance and microbiological controls. 3. Have a Doctorate and/or J.D. degree and also have one (1) year of comparable experience in the following: Comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: -Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates.-Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.- Product development, process development, scale-up, or commercial manufacturing.- Sterility assurance and microbiological controls. 4.. Have a MD, DO, DDS, DPM, or DVM degree. 5. Possess six (6) years of comparable experience in the following: Comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: -Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates.- Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.- Product development, process development, scale-up, or commercial manufacturing.- Sterility assurance and microbiological controls. 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, 03/25/2026. 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) 12901795 so that we may assist you faster.

Application Deadline: 2026-03-25