Biologics CMC Regulatory Manager (Hybrid)

Regeneron Pharmaceuticals, Inc.; New Jersey; Hybrid; USD 108,000 - 176,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager, CMC Regulatory Affairs - Biologics in Warren, New Jersey.

The role leads regulatory strategy across development, submissions, and post-market programs, collaborating with Global Regulatory Affairs and CMC teams to ensure compliance and timely filings. We value experience with biologics, strong communication, and the ability to translate complex regulatory requirements into actionable steps for cross-functional teams.

Qualifications

• Bachelor’s degree with 6+ years in pharmaceutical, biotechnology, or Health Authority settings.
• Advanced degree with 3+ years in similar 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.
• Experience engaging with FDA or other regulatory authorities preferred.

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 information request responses.
• Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.
• Identify regulatory process gaps and recommend efficiency improvements.

Skills

CMC Regulatory Affairs

Regulatory strategy

Regulatory compliance

Stakeholder management

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager, CMC Regulatory Affairs - Biologics in Warren, New Jersey.

The role leads regulatory strategy across development, submissions, and post-market programs, collaborating with Global Regulatory Affairs and CMC teams to ensure compliance and timely filings. We value experience with biologics, strong communication, and the ability to translate complex regulatory requirements into actionable steps for cross-functional teams.