Manager, CMC Regulatory Affairs - Biologics

Regeneron Pharmaceuticals • Warren, MI

21h • 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. Based on-site in Rensselaer, New York, this role leads regulatory strategy and compliance activities across product development, submissions, and post-market programs in collaboration with Global Regulatory Affairs and CMC partners.

The Manager leads CMC regulatory strategies for assigned biologic products, supports development from early phase through submission and post-market activities, and assesses changes and deviations for regulatory impact and filing requirements. The role also reviews filings for compliance, supports interactions with regulatory authorities, and develops guidance and process improvements to promote consistency and efficiency. The position calls for translating ambiguity into actionable steps and building alignment across teams.

Regeneron describes a competitive total rewards package that may include, depending on country and role, annual bonuses or other incentives, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits. The company is committed to an inclusive workplace and is an equal opportunity employer.

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 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 may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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