Regulatory Specialist

To qualify for the Regulatory Specialist (0696 series).. You must meet basic requirements by 07/24/2026: a bachelor's degree in a relevant field (e.g.. Quality assurance.. Data science.. Public health.. Engineering) OR comparable regulatory experience with FDA laws.. CGMP.. Or auditing. Additional experience levels apply based on degree.

• 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 from an accredited institution.
• OR comparable regulatory experience or FDA-regulated product lifecycle experience enforcing/ensuring compliance with FDA laws and regulations.
• Knowledge of the FD&C Act combined with experience in Current Good Manufacturing Practices (cGMP) or auditing FDA-regulated products.
• Experience interpreting statutes, regulations, guidance, and quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.
• Experience in product development, process development, scale-up, or commercial manufacturing.
• Experience in sterility assurance and microbiological controls.
• Bachelor's degree plus 1 year (Band Y) or 2 years (Band A) of comparable experience in cGMP manufacturing, clean room design/operations, equipment/process validation, or deviation investigations.
• Master's degree plus 0 years (Band Y) or 1 year (Band A) of comparable experience as above.
• Doctorate/J.D. plus 0 years of comparable experience.
• MD, DO, DDS, DPM, or DVM plus 0 years of comparable experience.

Support the preparation of regulatory documents for biologics submissions.

• Participate in professional development activities to progress toward independent practice.
• Assist senior staff in evaluating regulatory submissions by reviewing manufacturing information, quality data, and labeling materials.
• Apply scientific knowledge and regulatory understanding to assess submissions and data for compliance.
• Participate in multidisciplinary review teams and contribute to assessments of product safety and effectiveness.
• Engage in structured professional development aimed at advancing regulatory expertise.

U.S. Citizenship or U.S. National status must be met by closing date.

• Selected candidate will serve under a career or career-conditional appointment in the competitive service.
• Direct deposit of federal salary payments is required.
• FDA participates in e-Verify; all new hires must complete I-9 form.
• Males born after December 31, 1959 must be registered with Selective Service.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background investigation required; failure to pass may result in removal.
• Probationary period required for new competitive service appointments.

Complete federal benefits package including health, dental, vision, and life insurance.

• Retirement benefits through the Federal Employees Retirement System (FERS) and Thrift Savings Plan (TSP).
• Paid leave: annual leave, sick leave, and federal holidays.
• Telework eligibility as determined by agency policy.
• Access to employee assistance programs and professional development opportunities.

This position is filled under Title 21 authority (21 U.S.C. 379d-3a) as amended by the 21st Century Cures Act and Consolidated Appropriations Act.

• Active-duty U.S. Public Health Service Commissioned Corps Officers are encouraged to apply; options for active duty or civilian appointment exist.
• Candidates should be committed to improving federal government efficiency and upholding the Constitution.
• Foreign education must be evaluated by an accredited credential evaluation service.
• Reasonable accommodation for disabilities is available upon request.
• Vacancy Identification Number (VIN): 13007212.
• FDA Center for Biologics Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20993.

The Center for Biologics Evaluation and Research (CBER) is a branch of the U.S. Food and Drug Administration responsible for regulating biological products such as vaccines, blood products, and gene therapies. CBER ensures the safety, purity, and effectiveness of these products through scientific review and regulatory oversight. This Regulatory Specialist role supports CBER's mission by evaluating submissions and ensuring compliance with FDA standards, making it a key position for professionals dedicated to public health. Center for Biologics Evaluation and Research is named as the hiring organisation for the Regulatory Specialist post.