Biologics CMC Regulatory Affairs Manager (Hybrid)

BioSpace; New Jersey; Hybrid; USD 108,000 - 176,000; Full time

Job summary

Regeneron in Warren, New Jersey is seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team. This on-site role supports our biologics portfolio with a hybrid work model (4 days on-site).

You will lead regulatory strategies and drive development through submission and post-market activities. The role requires a Bachelor's with 6+ years or an advanced degree with 3+ years in pharmaceutical/biotech settings, plus 2–4 years in CMC regulatory affairs.

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.
• Strong understanding of global CMC Regulatory Affairs requirements.
• Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.

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 Reviewers Guides to improve consistency.
• Identify regulatory process gaps and recommend efficiency improvements.
• Translate ambiguity into actionable steps and build alignment across teams.

Education

Bachelor's degree

Advanced degree (MS/PhD)

Job description

Regeneron in Warren, New Jersey is seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team. This on-site role supports our biologics portfolio with a hybrid work model (4 days on-site).

You will lead regulatory strategies and drive development through submission and post-market activities. The role requires a Bachelor's with 6+ years or an advanced degree with 3+ years in pharmaceutical/biotech settings, plus 2–4 years in CMC regulatory affairs.