Temporary-Quality Reviewer / Batch Release Specialist
Regeneron Pharmaceuticals
Summary
Regeneron is seeking a Quality Reviewer / Batch Release Specialist supporting clinical and commercial lot release across our global product portfolio. In this role, you will safeguard product quality and regulatory compliance by verifying batch records and Certificates of Analysis against approved specifications, while collaborating with regulatory leads, global regulatory teams, and distribution compliance.
Job description
Discover your role
- Review batch status forms and CoAs for drug substance, formulated drug substance and drug product (labeled and unlabeled) to confirm lot disposition (released/quarantined), manufacturer/site, and shelf life/expiry
- Cross-check release testing panels, acceptance criteria, and release results in the CoA against approved specifications (e.g., P.5.1, S.4.1) and current regulatory filings (IMPD, IND, CTA, BLA, MAA)
- Verify manufacturing/testing site information, container closure, formulation, and dosage form align with the applicable regulatory dossier
- Identify and document discrepancies between CoA data and regulatory filings; assess whether discrepancies prevent lot release/endorsement
- Call out blocking discrepancies to appropriate collaborators (e.g., regulatory representatives, global regulatory leads, distribution compliance) for resolution or filing amendment
- Complete and submit required endorsement/release forms in the relevant quality system (e.g., Veeva, LIMS, or equivalent)
- Maintain accurate records of specification versions, filing versions, and prior review outcomes to support efficient future reviews
- Ensure activities follow applicable SOPs, work instructions, and cGMP requirements
- Support QP certification processes (EU/UK) and country-specific release requirements
This role requires
- A Bachelor's degree in life sciences, chemistry, pharmacy, or related field (advanced degree a plus) and 2+ years' experience in pharmaceutical/biotech Quality Assurance, Quality Control, Regulatory Affairs, or CMC operations
- Working knowledge of GMP, batch record review, and lot release/disposition processes
- Familiarity with regulatory filing structures (CTD Module 3, IMPD, IND, BLA/MAA)
- Experience with clinical trial or commercial lot release preferred
- Familiarity with QP certification processes and global distribution compliance preferred
Requirements
- Bachelor's degree in life sciences, chemistry, pharmacy, or related field
- 2+ years' experience in pharmaceutical/biotech Quality Assurance, Quality Control, Regulatory Affairs, or CMC operations
- Working knowledge of GMP, batch record review, and lot release/disposition processes
- Familiarity with regulatory filing structures (CTD Module 3, IMPD, IND, BLA/MAA)
- Experience with clinical trial or commercial lot release preferred
- Familiarity with QP certification processes and global distribution compliance preferred
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.