New · posted Oct 16
Regeneron · Biotechnology
Product Quality Compliance Specialist (CMC)
- Rensselaer, NY
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
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 Product Quality Compliance Specialist to support our Chemistry, Manufacturing, and Controls (CMC) activities. In this role, you will be responsible for being a quality representative for product and distribution compliance of Regeneron’s commercial programs including support with the product quality reviews (PQR). This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts and overseeing product management activities. Works collaboratively with CMC team members, alliance partners, collaborators and CMOs to ensure continuity of supply, consistency within and across programs, supply strategy alignment across functions, and compliance process efficiency.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
What you need
This role requires
Requires BS/BA in Chemistry, Biology or related field.
- Assoc QA Specialist: minimum of 0- 2 years relevant experience. with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience
- Specialist: minimum of 2 years relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.
Level is determined based on qualifications relevant to the role.
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.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
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.
What you'll do
Discover your role
- Oversees the global change management implementation plan
- Supports the evaluation of impact of proposed process changes, deviations and CAPAs on the end-to-end supply chain.
- Oversees the coordination and generation of the annual PQRs and yearly biologic product reports (YBPR).
- Assesses quality-related information to detect trends and works with subject matter experts to determine the need for actions required in response to those trends
- Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
- Interacts with global regulatory authorities in support of the CMC activities during Agency inspections.
- Collaborates cross-functionally to support regulatory release process and inventory review.
- Execute relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
- Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
- Support launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities, and launch material is aligned with the applicable regulatory dossiers.
- Responsible for providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, PDR, etc.), clinical notice of events and agency inspection responses in collaboration with CMC RA, QA, and SMEs as applicable.
- Facilitates the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT and SMEs as applicable.
Pay and benefits
$67,400 – $110,000 a year
Employer provided$67,400.00 - $110,000.00
Annual bonuses
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Rensselaer, NYWorking conditions
When & where
- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8:00 AM - 4:30 PM
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Job intelligence
The context around this role
Live data · October 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $67,400 | — | $110,000 |
| All US (middle half) | $77,000 | $77,000 | $78,000 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 86 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- GMP and compliance5
- Documentation and SOPs4
- Regulatory submissions4
- Investigations and CAPA2
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Regeneron on Regulatory Jobs
- 64
- Open roles
- 54
- Distinct roles
- 9
- Locations
By discipline
- Quality41 64%
- Regulatory20 31%
- Compliance & Safety3 5%
By level
- Associate & Specialist31 48%
- Manager20 31%
- Director7 11%
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Product Quality Compliance Specialist (CMC) at Regeneron
Open until filled. $67K–$110K a year, employer provided.