Manager, CMC Regulatory Affairs - Biologics

Regeneron Pharmaceuticals

1d • $108,000 - $176,000 • Onsite

About The Position

Regeneron is seeking a Manager, CMC Regulatory Affairs - Biologics to join its CMC Regulatory Affairs team and support its biologics portfolio. This on-site role leads regulatory strategy and compliance activities across development, submissions, and post-market programs, collaborating with Global Regulatory Affairs and CMC colleagues. The role is based in Rensselaer, New York.

The manager leads CMC regulatory strategies for assigned biologic products; supports CMC development from early phase through submissions and post-market activities; assesses changes and deviations for regulatory impact and filing requirements; and reviews filings for compliance with applicable regulations and guidelines. The role also supports regulatory authority interactions, develops working instructions, SOPs, and reviewer’s guides, and identifies process gaps and opportunities to improve efficiency. Success requires translating ambiguity into actionable steps and building alignment across teams.

Requirements

• Bachelor’s degree and 6+ years, or an advanced degree and 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 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 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 across teams and translate ambiguity into actionable steps.
• 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.
• Medical, dental, vision, life, and disability insurance benefits.
• Paid time off.
• Family support benefits.

What This Job Offers

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