Manager CMC Regulatory Affairs

Regeneron Pharmaceuticals•Warren, MI

1d•Onsite

About The Position

Regeneron is seeking a Manager, CMC Regulatory Affairs – Biologics to join its CMC Regulatory Affairs team and support the biologics portfolio. This on-site role leads regulatory strategy and compliance activities across development, regulatory submissions, and post-market programs, working with Global Regulatory Affairs and CMC collaborators. The position is based in Rensselaer, New York, or Warren, New Jersey. The role involves leading CMC regulatory strategies for assigned biologic products; supporting CMC development, submissions, and post-market work; assessing changes and deviations for regulatory impact; reviewing filings for compliance; and supporting interactions with regulatory authorities. The manager also develops working instructions, SOPs, and reviewer’s guides, identifies process gaps, and recommends efficiency improvements. Success requires translating ambiguity into actionable steps and aligning cross-functional teams. Regeneron describes its rewards package as potentially including 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. Availability may depend on 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 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.
Build alignment across teams and support training activities and efforts to address technical or regulatory knowledge gaps.