Biologics CMC Regulatory Affairs Manager (Hybrid)

Regeneron Pharmaceuticals, Inc.; Kentucky; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Retirement benefits

401(k) matching

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. in Warren, New Jersey is seeking a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy and compliance for our biologics portfolio.

The role is hybrid with on-site collaboration four days per week and requires strong cross-functional partnership across development, submissions, and post-market activities. The successful candidate will drive CMC regulatory submissions, global regulatory requirements, and interactions with authorities, while

Qualifications

• Bachelor's degree with 6+ years in pharma/biotech 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.
• 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.
• Translate ambiguity into actionable steps and build alignment across teams.

Skills

Regulatory strategy

Regulatory compliance

Cross-functional collaboration

Communication skills

Negotiation

Strategic thinking

Problem solving

Education

Bachelor's degree in pharmaceutical/biotechnology/health authority settings

Advanced degree (MS/PhD) in related field

Job description

Regeneron Pharmaceuticals, Inc. in Warren, New Jersey is seeking a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy and compliance for our biologics portfolio.

The role is hybrid with on-site collaboration four days per week and requires strong cross-functional partnership across development, submissions, and post-market activities. The successful candidate will drive CMC regulatory submissions, global regulatory requirements, and interactions with authorities, while