Regulatory Scientist

About the role

This position is being filled under a streamlined 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 A. (GS 11 equivalent).

Responsibilities

• Applies scientific knowledge and regulatory understanding to assess data submitted by manufacturers and other stakeholders.
• Evaluates regulatory submissions, including comprehensive review of manufacturing information, quality data, and labeling materials for compliance with applicable regulations using established methodologies and standards.
• Contributes to the preparation of regulatory communications with appropriate technical depth and may serve as a technical resource on review teams.
• Provides analyses and recommendations for high-priority consumer complaints and product complaints related to nutrition, toxic elements, allergens, foodborne illness, dietary supplements, infant formula, etc.
• Manages and coordinates HFP-related complaints received from consumers, industry, medical professionals, State, Local, Tribal and Territorial (SLTT) authorities, and other Federal agencies and public health partners.

Requirements

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Qualifications

• Minimal Qualifications Requirements for the Regulatory Scientist RC-696-00: 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 4 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.

• IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS FOR THE BAND A.
• 1. Have a bachelor's degree and also have two (2) years of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution.
• 2. Have a master's degree and also have one (1) years of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution.
• 3. Have a Doctorate and/or J.D. degree and zero (0) year of comparable experience
• 4. Have a MD, DO, DDS, DPM, or DVM degree.
• 5. Possess four (4) years of comparable experience in conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Additional Information

• Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement.
• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• If you are serving, or have served in the last 5 years (from 07/14/2026) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.