Manager, CMC Regulatory Affairs - Biologics

Regeneron Pharmaceuticals • Warren, MI

7d • Onsite

About The Position

Regeneron is seeking a Manager, CMC Regulatory Affairs to support its biologics portfolio. The role leads regulatory strategy and compliance activities across product development, regulatory submissions, and post-market programs, working with Global Regulatory Affairs and CMC collaborators. The position is on-site in Rensselaer, New York; Warren, New Jersey; or Tarrytown, New York.

The successful candidate translates ambiguity into actionable steps and builds alignment across teams. The role also supports training and addresses technical or regulatory knowledge gaps. Regeneron describes its workplace as inclusive and offers a competitive total rewards package that may vary by country and role.

Requirements

• Bachelor’s degree with at least 6 years of experience, or an advanced degree with at least 3 years of experience, 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.
• 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.

Nice To Haves

• Experience supporting biologic products.
• Experience engaging with the FDA or other regulatory authorities.

Responsibilities

• Lead CMC regulatory strategies for assigned biologic products.
• Support CMC development from early phase through 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 responses to information requests.
• Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.
• Identify regulatory process gaps and recommend efficiency improvements.
• Build alignment and cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
• Support training activities and proactively address technical or regulatory knowledge gaps.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits, including medical, dental, vision, life, and disability insurance.
• Paid time off.
• Family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager