Manager CMC Regulatory Affairs

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 108,000 - 176,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a Manager, CMC Regulatory Affairs – Biologics to lead regulatory strategy and compliance across development, submissions and post‑market programs. This on-site role collaborates with Global Regulatory Affairs and CMC teams to drive biologics programs for patients worldwide.

The position requires 6+ years in pharma/biotech or 3+ with advanced degree, with CMC submissions experience and strong cross-functional skills.

Qualifications

• Bachelor’s degree with 6+ years in pharmaceutical/biotech or Health Authority settings.
• 2–4 years of CMC regulatory affairs experience.
• Strong understanding of global CMC regulatory requirements.
• Experience delivering CMC sections of MAAs, CTAs/INDs, and post‑approval submissions.
• Experience with biologics and regulatory authority interactions preferred.

Responsibilities

• Lead CMC regulatory strategies for assigned biologic products.
• Support development through early phase, submission and post-market activities.
• Assess regulatory impact of changes and deviations.
• Review filings for compliance with regulations.
• Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.
• Identify regulatory process gaps and propose efficiency improvements.

Skills

Strong communication

Negotiation

Strategic thinking

Problem solving

Cross-functional collaboration

Prioritization

Training support

Education

Bachelor's degree in pharma/biotech

Advanced degree

Job description

Manager, CMC Regulatory Affairs – Biologics

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 work with a fast‑growing, science‑driven organization, which makes a meaningful difference for patients worldwide.

Location & Work Model

Location: Rensselaer, New York or Warren, New Jersey
Work model: On‑site

Responsibilities

• 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.

Requirements

• 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.

Salary Range

Salary Range (annually) $108,000.00 - $176,000.00

Equal Opportunity

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.

Background Checks

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.

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/.

Company Overview

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award‑winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020 and Forbes JUST companies in 2020, among others.