Temporary-Quality Reviewer / Batch Release Specialist

Regeneron Pharmaceuticals, Inc.; Troy (MI); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Temporary-Quality Reviewer / Batch Release Specialist to support clinical and commercial lot release across our global portfolio.

You will verify batch records and CoAs against specifications, collaborating with regulatory leads and distribution compliance to safeguard product quality and regulatory compliance. The role offers remote or on-site work in Rensselaer, NY, with responsibilities spanning review, discrepancy identification, and endorsement

Qualifications

• Bachelor's degree in life sciences, chemistry, pharmacy, or related field (advanced degree a plus).
• 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.

Responsibilities

• Review batch status forms and CoAs for drug substance, formulated drug substance, and drug product to confirm lot disposition, manufacturer/site, and shelf life/expiry.
• Cross-check release testing panels, acceptance criteria, and release results in the CoA against approved specifications and regulatory filings.
• Verify manufacturing/testing site information, container closure, formulation, and dosage form align with the regulatory dossier.
• Identify and document discrepancies between CoA data and regulatory filings; assess impact on lot release.
• Call out blocking discrepancies to regulators and collaborators for resolution or filing amendment.
• Complete and submit endorsement/release forms in the quality system (e.g., Veeva, LIMS).
• Maintain records of specification versions, filing versions, and prior review outcomes to support future reviews.
• Ensure activities follow SOPs, work instructions, and cGMP requirements.
• Support QP certification processes (EU/UK) and country-specific release requirements.

Skills

GMP knowledge

Batch release

CoA review

Quality Assurance

Education

Bachelor's degree in life sciences/chemistry/pharmacy or related field

Tools

Veeva

LIMS

Job description

Temporary-Quality Reviewer / Batch Release Specialist

Build our future together:
At 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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: US
• Work model/flexibility: Remote or on-site in Rensselaer, NY (5 days/week)

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

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire .

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

How We Hire

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

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