Manager CMC Regulatory Affairs

Regeneron Pharmaceuticals • Warren, MI

6d • $108,000 - $176,000 • Hybrid

About The Position

Regeneron is seeking a Manager, CMC Regulatory Affairs - Biologics to join its CMC Regulatory Affairs team and support its biologics portfolio. Based in Warren, New Jersey, the role follows a hybrid work model with four days per week on-site. The manager leads regulatory strategy and compliance activities across development, submissions, and post-market programs, collaborating with Global Regulatory Affairs and CMC colleagues. The position supports biologic products through early development, regulatory submissions, and post-market activities, and contributes to improving regulatory processes and consistency.

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 authorization applications, 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.
• Support training activities and proactively address technical or regulatory knowledge gaps.
• Build alignment and cross-functional partnerships while managing competing priorities and delivering results in dynamic environments.

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 coverage.
• Paid time off.
• Family support benefits.

What This Job Offers

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