New · posted Oct 15
Regeneron · Biotechnology
Manager, CMC Regulatory Affairs - Biologics
- Rensselaer, NY
- On-site
- Full-time
- Manager
Open until filled
The role
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our biologics portfolio in an on-site work model. In this role, you will lead regulatory strategy and regulatory compliance activities across development, submissions, and post-market programs while collaborating with Global Regulatory Affairs and CMC collaborators.
This position offers the opportunity to give to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
What you need
This role requires
- Bachelor’s degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings.
- 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
- Strong understanding of global CMC Regulatory Affairs requirements.
- Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
- Experience supporting biologic products preferred.
- Experience engaging with FDA or other regulatory authorities preferred.
- Strong communication, negotiation, strategic thinking, and problem-solving skills.
- Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
- Ability to support training activities and proactively address technical or regulatory knowledge gaps.
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
- Lead CMC regulatory strategies for assigned biologic products.
- Support CMC development through early phase, submission, and post-market activities.
- Assess changes and deviations for regulatory impact and filing requirements.
- Review regulatory filings for compliance with applicable regulations and guidelines.
- Support regulatory authority interactions, including meetings and information request responses.
- Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.
- Identify regulatory process gaps and recommend efficiency improvements.
- You translate ambiguity into actionable steps and build alignment across teams.
Pay and benefits
$108,000 – $176,000 a year
Employer provided$108,000.00 - $176,000.00
Annual bonuses or incentive plans
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
Work model: On-site
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 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Manager roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $108,000 | — | $176,000 |
| All US (middle half) | $157,000 | $171,000 | $180,750 |
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 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 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 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Regulatory submissions4
- GMP and compliance3
- Lab testing and methods1
- Documentation and SOPs1
- Investigations and CAPA1
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
- 53
- Open roles
- 47
- Distinct roles
- 9
- Locations
By discipline
- Quality35 66%
- Regulatory15 28%
- Compliance & Safety3 6%
By level
- Associate & Specialist26 49%
- Manager15 28%
- Director7 13%
More roles at Regeneron
- View role
Manager, CMC Regulatory Affairs - Biologics
Rensselaer, NY +1 moreManagerBiotechnology$108K–$176K
- View role
Assoc CMC Product Quality Compliance Specialist
United StatesAssociate & SpecialistBiotechnology$62K–$92K
- View role
Associate CMC Product Quality Compliance Specialist
United StatesAssociate & SpecialistBiotechnology$62K–$92K
- View role
Assoc CMC Regulatory Sciences Specialist
United StatesAssociate & SpecialistBiotechnology$62K–$92K
Similar Regulatory CMC roles elsewhere
- View role
Senior Manager, CMC Regulatory Affairs (Biologics)
Travere TherapeuticsSan Diego, CA · HybridManagerBiotechnology$132K–$172K
- View role
Senior Manager, Regulatory Affairs, CMC
Stoke TherapeuticsBedford, MA · HybridManagerBiotechnology$181K–$213K
- View role
Senior Manager, Regulatory Affairs CMC
Fate TherapeuticsSan Diego, CAManagerBiotechnology$160K–$190K
- View role
Senior Manager, Regulatory Affairs CMC
CytokineticsRadnor, PA · HybridManagerBiotechnology$177K–$207K
Manager, CMC Regulatory Affairs - Biologics at Regeneron
Open until filled. $108K–$176K a year, employer provided.