Job Description
The Center for Biologics Evaluation and Research (CBER) at the FDA is hiring a Regulatory Specialist to aid the preparation of regulatory documents and evaluate submissions for biologics.
You’ll perform alongside experienced staff, applying scientific and regulatory expertise to assess manufacturing data, grade information, and labeling materials.
This role is best-suited for professionals with a background in standard assurance, public health, engineering, or related fields who want to contribute to public health by making sure the safety and effectiveness of biological solutions.
The role is set at the FDA's White Oak campus in Silver Spring, Maryland, and provides telework eligibility as determined by agency policy.
Salary & Compensation
Salary: $70,623 - $113,056 per year.
Qualification
To qualify for the Regulatory Specialist (0696 series).. You must encounter fundamental conditions by 07/24/2026: a bachelor's degree in a related field (e.g.. Caliber assurance.. Records science.. Public health.. Engineering) OR comparable regulatory expertise with FDA laws.. CGMP.. Or auditing. Additional know-how levels register located on degree.
- Bachelor's degree or higher in grade assurance/management, figures 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 background or FDA-regulated solution lifecycle expertise enforcing/securing compliance with FDA laws and regulations.
- Insight of the FD&C Act combined with know-how in Present Solid Manufacturing Practices (cGMP) or auditing FDA-regulated items.
- Background interpreting statutes, regulations, guidance, and quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.
- Expertise in product development, routine development, scale-up, or commercial manufacturing.
- Know-how in sterility assurance and microbiological controls.
- Bachelor's degree plus 1 year (Band Y) or 2 years (Band A) of comparable background in cGMP manufacturing, clean room design/operations, equipment/procedure validation, or deviation investigations.
- Master's degree plus 0 years (Band Y) or 1 year (Band A) of comparable expertise as above.
- Doctorate/J.D. Plus 0 years of comparable know-how.
- MD, DO, DDS, DPM, or DVM plus 0 years of comparable background.
Role Responsibilities
Back the preparation of regulatory documents for biologics submissions.
- Participate in expert development activities to progress toward independent practice.
- Assist experienced workforce in evaluating regulatory submissions by reviewing manufacturing information, standard information, and labeling materials.
- Apply scientific understanding and regulatory understanding to assess submissions and records for compliance.
- Participate in multidisciplinary examine teams and contribute to assessments of offering safety and effectiveness.
- Engage in structured professional development aimed at advancing regulatory expertise.
Conditions & Requirements
U.S. Citizenship or U.S. National status must be met by closing date.
- Selected applicant will cater to under a profession or career-conditional appointment in the competitive service.
- Straight deposit of federal salary payments is called for.
- FDA participates in e-Verify; all new hires must finalize I-9 form.
- Males born after December 31, 1959 must be registered with Selective Offering.
- Financial Disclosure may be required.
- Ethics Clearance may be needed.
- Background investigation required; failure to pass may outcome in removal.
- Probationary period called for for new competitive solution appointments.
Benefits
Complete federal upsides package covering health, dental, vision, and life insurance.
- Retirement advantages through the Federal Employees Retirement System (FERS) and Thrift Savings Scheme (TSP).
- Paid exit: annual leave, sick depart, and federal holidays.
- Telework eligibility as determined by agency policy.
- Access to employee assistance programs and skilled development prospects.
How You Will Be Evaluated
This is a Title 21 announcement; traditional rating, ranking, and veterans' preference don’t put in.
- You’ll be evaluated set on how well you gather the qualifications above.
- If referred to the hiring manager, you may be further evaluated via meeting, operate samples, writing samples, performance evaluations, expert references, or oral presentation.
- Failure to comply with additional assessment needs will effect in removal from consideration.
- Candidates are encouraged to respond to four optional essay questions per Executive Order 14170; answers aren’t scored but reviewed by hiring manager and agency leadership.
Required Documents
Resume: Must contain role title, employer label, start/end dates (month/year), pay (or grade/step), hours per week, and tasks performed. Two-page restrict recommended.
- Transcripts: Unofficial transcripts or course list showing courses, grades, completion dates, and quarter/semester hours. Needed for education-based qualification.
- Cover Letter (optional).
- DD-214/Statement of Offering (if relevant).
- Disability Letter (Schedule A or VA).
- License (if suitable).
- PCS Orders (if relevant).
- Performance Appraisal (if suitable).
- Skilled Certification (if relevant).
- Separation Spot (RIF) (if applicable).
How to Apply
Unseal the authorized submission portal and with your the formal application portal/Login.gov account.
- Wrap up the online application questionnaire, such as the optional essay questions if you opt for to respond.
- Attach your federal resume and all called for supporting documents (transcripts, etc.).
- Evaluate your submission for completeness and hand in before 11:59 PM Eastern Time on 07/24/2026.
- After submission, you’ll obtain an acknowledgment email and status updates via the authorized submission portal.
Additional Information
This role 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 Solution Commissioned Corps Officers are encouraged to register; choices for active task or civilian appointment exist.
- You should be committed to improving federal public sector efficiency and upholding the Constitution.
- Foreign education must be evaluated by an accredited credential evaluation offering.
- Sensible accommodation for disabilities is on offer upon request.
- Vacancy Identification Figure (VIN): 13007212.
- FDA Center for Biologics Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20993.
About Company
The Center for Biologics Evaluation and Research (CBER) is a branch of the U.S. Food and Drug Administration responsible for regulating biological offerings such as vaccines, blood products, and gene therapies. CBER guarantees the safety, purity, and effectiveness of these solutions through scientific assess and regulatory oversight. This Regulatory Specialist role backs CBER's mission by evaluating submissions and ensuring compliance with FDA standards, making it a key post for professionals dedicated to public health. Center for Biologics Evaluation and Research is named as the hiring organization for the Regulatory Specialist post.
Center for Biologics Evaluation and Research employment opportunities
FAQs
What does a Regulatory Specialist at FDA CBER do day-to-day?
You’ll arrange regulatory documents, review manufacturing and standard figures, aid with evaluating submissions for biologics, and participate in multidisciplinary assess teams to assess item safety and effectiveness.
Can expertise substitute for a bachelor’s degree for this role?
Yes, comparable regulatory experience or FDA-regulated item lifecycle background can substitute for education. Precise know-how in cGMP, auditing, or product development may qualify you without a degree.
Is this role remote or onsite?
This role isn’t remote; it’s located at the FDA White Oak campus in Silver Spring, MD. Telework is eligible as determined by agency policy.
What is the picking procedure under Title 21 authority?
Traditional rating and ranking don’t put in. You’ll be evaluated on qualifications, and if referred, may be assessed via meeting, function samples, or presentations. Veterans' preference doesn’t register.
What documents are crucial to hand in with my submission?
A resume (two-page restrict recommended) and transcripts (unofficial accepted) are needed. Additional documents like DD-214, SF-50, or certifications may be needed if suitable.