Manager Combination Products - Regulatory Affairs

Regeneron seeks a Regulatory Affairs Manager to oversee combination product development and global regulatory submissions. The role involves supporting CMC compliance, design controls, and stakeholder engagement across early-stage through post-market activities in an onsite position.

Responsibilities

• Support combination product development from early phase through post-market activities
• Review regulatory filings including INDs, BLAs, MAAs, annual reports, and supplements
• Develop design control documentation and quality systems for combination products
• Assess regulatory impact of changes and deviations; support authority meetings and inspections
• Create SOPs and documentation; identify process gaps and regulatory intelligence activities

Requirements

• Bachelor's degree with 6+ years pharmaceutical/biotech experience, or advanced degree with 3+ years
• 2-4 years CMC Regulatory Affairs experience supporting worldwide regulations
• Strong knowledge of global CMC requirements, combination products, and human factors
• Experience delivering marketing authorizations, CTAs, INDs, and post-approval submissions
• Preferred experience with biologics, combination products, and FDA engagement
• Ability to mentor staff, assess regulatory impact, and support compliance activities
• Strong communication, negotiation, and cross-functional collaboration skills