Biologics CMC Regulatory Affairs Manager - On-site NY

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 108,000 - 176,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team on-site in Rensselaer, NY. You will lead regulatory strategy and ensure compliance across development, submissions, and post-market programs for our biologics portfolio.

You will collaborate with Global Regulatory Affairs and CMC colleagues to drive efficient filings, address regulatory questions, and improve processes while delivering high-quality outcomes for patients

Qualifications

• Bachelor’s degree with 6+ years, or advanced degree with 3+ years in pharmaceutical/biotech settings.
• 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
• Experience delivering CMC sections of MAAs, CTA/INDs, and post-approval submissions.
• Experience supporting biologic products preferred.
• Experience engaging with FDA or other regulatory authorities preferred.
• Strong communication, negotiation, strategic thinking, and problem-solving skills.

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

CMC Regulatory Affairs

Global regulatory experience

Regulatory strategy

Education

Bachelor's degree

Advanced degree

Job description

Regeneron Pharmaceuticals is seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team on-site in Rensselaer, NY. You will lead regulatory strategy and ensure compliance across development, submissions, and post-market programs for our biologics portfolio.

You will collaborate with Global Regulatory Affairs and CMC colleagues to drive efficient filings, address regulatory questions, and improve processes while delivering high-quality outcomes for patients