CMC Regulatory Affairs Manager, Cell & Gene Therapy

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 108,000 - 176,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategies across development, submissions, and post-market programs for biologics, including cell and gene therapy products and synthetic oligonucleotides.

This on-site role collaborates with Global Regulatory Affairs and CMC teams to ensure compliance and timely filings. The role requires 2–4 years of CMC Regulatory Affairs experience, strong communication, and the

Qualifications

• Bachelor’s degree with 6+ years or advanced degree with 3+ years in pharmaceutical, biotechnology, or Health Authority settings.
• 2–4 years of CMC Regulatory Affairs experience with worldwide regulations.
• Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
• Experience with cell and gene therapy products and synthetic oligonucleotides preferred.
• Experience engaging with FDA or other regulatory authorities preferred.
• Strong communication, negotiation, strategic thinking, and problem-solving skills.
• Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.

Responsibilities

• Lead CMC regulatory strategies for assigned products including cell and gene therapy products and synthetic oligonucleotides.
• 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 information request responses.
• Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Regulatory compliance

Education

Bachelor’s degree in pharmaceutical/biotech field

Advanced degree (MS/PhD) in related field

Job description

Regeneron Pharmaceuticals, Inc. in the United States seeks a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategies across development, submissions, and post-market programs for biologics, including cell and gene therapy products and synthetic oligonucleotides.

This on-site role collaborates with Global Regulatory Affairs and CMC teams to ensure compliance and timely filings. The role requires 2–4 years of CMC Regulatory Affairs experience, strong communication, and the