Temporary-Quality Reviewer / Batch Release Specialist

<strong>Temporary-Quality Reviewer / Batch Release Specialist - </strong><strong>R50989<br><br></strong><strong>Position Description<br><br></strong>At a Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are 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.<br><br><strong>Roles Responsibilities<br><br></strong><ul><li> 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</li><li> 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)</li><li> Verify manufacturing/testing site information, container closure, formulation, and dosage form align with the applicable regulatory dossier</li><li> Identify and document discrepancies between CoA data and regulatory filings; assess whether discrepancies prevent lot release/endorsement</li><li> Call out blocking discrepancies to appropriate collaborators (e.g., regulatory representatives, global regulatory leads, distribution compliance) for resolution or filing amendment</li><li> Complete and submit required endorsement/release forms in the relevant quality system (e.g., Veeva, LIMS, or equivalent)</li><li> Maintain accurate records of specification versions, filing versions, and prior review outcomes to support efficient future reviews</li><li> Ensure activities follow applicable SOPs, work instructions, and cGMP requirements</li><li> Support QP certification processes (EU/UK) and country-specific release requirements<br><br></li></ul><strong>Skills<br><br></strong><ul><li> A Bachelor's degree in life sciences, chemistry, pharmacy, or related field (advanced degree a plus)</li><li> 2 years' experience in pharmaceutical/biotech Quality Assurance, Quality Control, Regulatory Affairs, or CMC operations</li><li> Working knowledge of GMP, batch record review, and lot release/disposition processes</li><li> Familiarity with regulatory filing structures (CTD Module 3, IMPD, IND, BLA/MAA)</li><li> Experience with clinical trial or commercial lot release preferred</li><li> Familiarity with QP certification processes and global distribution compliance preferred<br><br></li></ul><strong>Education<br><br></strong><ul><li> Bachelor's degree in life sciences, chemistry, pharmacy, or related field (advanced degree a plus)</li></ul>

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