Hybrid Regulatory Specialist bei Department of Health and Human Services

Regulatory Specialist

Department: Department of Health and Human Services

Location(s): College Park, Maryland

Salary Range: $120579 - $167904 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:

• Reviews recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug and Cosmetic (FD and C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability. Reviews inspection reports submitted by field investigators and other information and data to determine compliance with applicable laws and regulations. Responsible for implementing and managing a full range of compliance actions, both administrative and judicial, including casework and related functional responsibilities in the area of human foods. Provides scientific and technical input on compliance issues and in regulatory meetings to ensure consistency of interpretation of Current Good Manufacturing Practices (CGMPs) and other foods regulations. Leads or participates in cross-functional working groups, regulatory task forces, and agency-wide initiatives focused on enhancing program effectiveness, developing enforcement policies, and improving national compliance outcomes. Evaluates, identifies, and addresses significant problems and issues in areas where nominal policy guidance exists, and requires prompt remediation. Writes technical reports or completes technical analyses based on inspectional and sampling findings of foods and/or dietary supplements and makes recommendations for further action. Provides an accurate assessment of the state of compliance of a firm or corporation on regulatory compliance and enforcement. Perform other duties as assigned.

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 07/23/2025: Basic Qualification Requirements: Have 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 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. 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 have 4 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a master's degree and have 3 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a Doctorate and/or J.D. degree and have 1 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have 6 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing.

How to Apply: 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, 07/23/2025. 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://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. 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 encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. 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 [email protected]. 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) 12764884 so that we may assist you faster.

Application Deadline: 2025-07-23