Mgr CMC Regulatory Affairs

Regeneron Pharmaceuticals • Rensselaer, IN

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, based in Rensselaer, New York, leads regulatory strategy and compliance activities across development, submissions, and post-market programs, in collaboration with Global Regulatory Affairs and CMC colleagues.

The position supports CMC development from early phase through submissions and post-market activities, including assessing changes and deviations for regulatory impact and filing requirements, reviewing filings for compliance, and supporting regulatory authority interactions. The role also develops working instructions, SOPs, and reviewer’s guides, and identifies regulatory process gaps and opportunities for improvement. The annual salary range is $108,000 to $176,000.

Requirements

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

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits.

What This Job Offers

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