Temporary-Quality Reviewer / Batch Release Specialist
About The Position
Regeneron is seeking a Quality Reviewer / Batch Release Specialist to support clinical and commercial lot release across its global product portfolio. The role safeguards product quality and regulatory compliance by verifying batch records and Certificates of Analysis (CoAs) against approved specifications and coordinating with regulatory and distribution-compliance collaborators. The specialist reviews batch status forms and CoAs for drug substance, formulated drug substance, and drug product; checks release information against approved specifications and current regulatory filings; documents and escalates discrepancies; and completes release or endorsement forms in the relevant quality system. The position also maintains review records, follows SOPs and cGMP requirements, and supports QP certification and country-specific release requirements. The role is a six-month contract and may be remote or on-site in Rensselaer, New York.
Requirements
- Bachelor's degree in life sciences, chemistry, pharmacy, or a related field.
- At least 2 years of experience in pharmaceutical or biotechnology Quality Assurance, Quality Control, Regulatory Affairs, or CMC operations.
- Working knowledge of GMP, batch record review, and lot release or disposition processes.
- Familiarity with regulatory filing structures, including CTD Module 3, IMPD, IND, BLA, and MAA.
Nice To Haves
- Advanced degree.
- Experience with clinical trial or commercial lot release.
- Familiarity with QP certification processes and global distribution compliance.
Responsibilities
- Review batch status forms and CoAs for drug substance, formulated drug substance, and labeled or unlabeled drug product to confirm lot disposition, manufacturer or site, and shelf life or expiry.
- Cross-check release testing panels, acceptance criteria, and CoA results against approved specifications and current regulatory filings.
- Verify that manufacturing and 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, and assess whether they prevent lot release or endorsement.
- Escalate blocking discrepancies to regulatory representatives, global regulatory leads, distribution compliance, or other appropriate collaborators for resolution or filing amendment.
- Complete and submit required endorsement or release forms in the relevant quality system, such as Veeva, LIMS, or equivalent.
- Maintain accurate records of specification versions, filing versions, and previous review outcomes.
- Ensure activities follow applicable SOPs, work instructions, and cGMP requirements.
- Support QP certification processes for the EU and UK, as well as country-specific release requirements.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (including medical, dental, vision, life, and disability), paid time off, and family support benefits.
