Center for Biologics Evaluation and Research (1 Job)
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About Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research (CBER) is a center within the U.S. Food and Drug Administration (FDA) responsible for regulating biological products for human use, including vaccines, blood and blood products, cellular and gene therapy products, allergenics, tissues, and xenotransplantation. CBER ensures the safety, effectiveness, and availability of these products and educates the public on their safe and appropriate use. The center is headquartered at 5630 Fishers Lane in Rockville, Maryland, and operates as part of the federal government under the Department of Health and Human Services.
As of July 2026, CBER continues to oversee the regulation of biologics, with recent activities including the launch of the Support for Clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program and ongoing work on artificial intelligence and machine learning for CBER-regulated products. The center also participates in public meetings such as the 2024 CBER Patient and Care Partner Listening Meetings and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting scheduled for July 29, 2026.
CBER regulates vaccines, blood, biologics, cellular and gene therapies, allergenics, tissues, and xenotransplantation.
Official source ↗1-888-INFO-FDA (1-888-463-6332)
Official source ↗CBER has a Rare Disease Program to support development of therapies for rare diseases.
Official source ↗Search for FDA guidance documents by product area, including biologics, via the FDA Guidance Document Search.
Official source ↗CBER follows the No FEAR Act; careers and job training information available on FDA's website.
Official source ↗Recent activity
Recent dated updates published on organization-controlled public pages.
Cellular, Tissue, and Gene Therapies Advisory Committee Meeting Announcement
An advisory committee meeting on cellular, tissue, and gene therapies is scheduled for July 29, 2026, with updated information as of July 16, 2026.
Read official source ↗FDA/Health and Environmental Sciences Institute/Safety Pharmacology Society Hybrid Workshop
A hybrid workshop on ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology is scheduled for July 28, 2026.
Read official source ↗Voluntary Recall of Cyclophosphamide for Injection Due to Particulate Matter
Sunny Pharmtech, Inc. issued a nationwide recall of Cyclophosphamide for Injection due to presence of particulate matter identified as steel.
Read official source ↗Voluntary Recall of Cefazolin in Dextrose Injection Due to Particulate Matter
Baxter International Inc. issued a nationwide recall of Cefazolin in Dextrose Injection due to particulate matter (cardboard) found in the solution.
Read official source ↗FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
FDA announced the first participant selected for the TEMPO pilot program for digital health devices, a step toward modernizing device regulation.
Read official source ↗FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
FDA announced actions to remove outdated color additive authorizations in food, continuing efforts to ensure food safety.
Read official source ↗FDA Releases National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan for 2026–2030
FDA released the NARMS strategic plan for 2026-2030, outlining goals for monitoring antimicrobial resistance.
Read official source ↗Recall of Shell Eggs Due to Possible Salmonella Contamination
Midwest Poultry Services, L.P. recalled shell eggs due to potential Salmonella Enteritidis contamination.
Read official source ↗FDA Launches Pilot Program to Incentivize Manufacturing of Animal Drug Products in the U.S.
FDA launched a pilot program to encourage domestic manufacturing of animal drug products.
Read official source ↗FDA Releases Blueprint to Expand Animal Drug Development for Minor Uses and Minor Species
FDA released a blueprint to expand animal drug development for minor uses and minor species.
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Exploring Career Opportunities at CBER
CBER, as part of the FDA, offers a range of federal career opportunities in biologics regulation. Interested applicants should monitor USAJOBS.gov for postings and review the FDA's No FEAR Act page for employment information.
Reference source ↗Preparing Your Application for a Federal Biologics Role
When applying to CBER, ensure your resume highlights relevant experience in biological sciences, regulatory affairs, or public health. Familiarize yourself with the FDA's guidance documents and regulatory processes to demonstrate your knowledge.
Reference source ↗Understanding CBER's Role in Biologics Regulation
CBER oversees a wide range of biological products, from vaccines to gene therapies. Understanding the center's mission and recent initiatives, such as the Rare Disease Program and AI/ML efforts, can help applicants align their skills with the agency's priorities.
Reference source ↗Where candidates can start with the latest openings
Center for Biologics Evaluation and Research currently has 1 published opening. Applicants can compare Regulatory Specialist, Center for Biologics Evaluation and Research Job in Silver Spring, then review each vacancy page for qualifications, duties, location and application instructions before deciding which role best matches their background.
Reference source ↗
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