New · posted Oct 23
Regeneron · Biotechnology
Senior Specialist, CMC Regulatory Affairs - Quality Compliance
- Rensselaer, NY
- On-site
- Full-time
- Senior & Principal
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 Senior Specialist, CMC Regulatory Affairs - Quality Compliance, to join our CMC Regulatory Affairs team, supporting our manufacturing and quality teams in a onsite work model. In this role, you will assess regulatory impact from quality events and quality system actions while driving compliance activities to resolution while collaborating with Quality, Manufacturing, Supply, and CMC Regulatory Affairs stakeholders. 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
- Bachelor’s degree in chemistry, biology, or a related field.
- 2+ years of relevant biotechnology or pharmaceutical industry experience.
- Advanced qualification or CMC experience may be considered.
• Strong CMC and quality compliance experience, including driving quality system actions and events to closure. - Proven experience assessing regulatory impact of change control
- Strong understanding of quality principles within a regulated manufacturing environment.
- Ability to develop proficiency in electronic quality, regulatory, and document management systems.
- Experience running work within digital workflows and data repositories such as QMS systems and Veeva Vault.
- Strong relationship-building skills with internal and external stakeholders.
- Clear, precise communication skills across organizational levels.
- Strong attention to detail and adaptability to change.
- Dedication to continuous process improvement.
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
- Assess product license impact from quality system changes and deviations.
- Evaluate regulatory impact of manufacturing processes and procedures as a subject matter expert.
- Own change controls, document workflows, and corrective and preventive actions through closure.
- Draft procedures, reports, and presentation materials with a high standard of quality.
- Lead quality compliance onboarding activities for the CMC Regulatory Affairs team.
- Collect, analyze, and present quality compliance metrics to CMC Regulatory Affairs.
- Monitor compliance support requests, triaging and escalating issues appropriately.
• You build positive relationships while supporting continuous process improvement.
Pay and benefits
$78,700 – $128,700 a year
Employer provided$78,700.00 - $128,700.00
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
Site: Rensselaer
Work Model: Onsite
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 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 31% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Senior & Principal roles in the US7 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $78,700 | — | $128,700 |
| All US (middle half) | $120,000 | $150,500 | $193,250 |
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 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 87 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.
- Quality systems and risk8
- GMP and compliance5
- Documentation and SOPs4
- Collaboration and leadership4
- Investigations and CAPA1
- Validation and qualification1
- Data and digital systems1
Company hiring pulse
Regeneron on Regulatory Jobs
- 81
- Open roles
- 69
- Distinct roles
- 9
- Locations
By discipline
- Quality57 70%
- Regulatory21 26%
- Compliance & Safety3 4%
By level
- Associate & Specialist40 49%
- Manager21 26%
- Senior & Principal12 15%
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Senior Specialist, CMC Regulatory Affairs - Quality Compliance at Regeneron
Open until filled. $79K–$129K a year, employer provided.