Manager Combination Products - Regulatory Affairs

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team, supporting our combination product business area in an onsite work model. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location: Rensselaer, New York
Work Model: Onsite, 5 days per week

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 changes and deviations for regulatory impact and submission requirements.
• Support regulatory authority meetings, responses, and inspections.
• Create SOPs, Working Instructions, and Reviewers Guides.
• Identify process gaps and support regulatory intelligence activities.
• Translate ambiguity into action and build effective stakeholder partnerships.

Requirements

• Bachelor's degree with 6+ years of related experience, or advanced degree with 3+ years of related experience in pharmaceutical or biotechnology settings.
• 2-4 years of CMC Regulatory Affairs experience supporting worldwide regulations.
• Strong understanding of global CMC Regulatory Affairs requirements, including combination products and human factors.
• Experience delivering marketing authorizations, CTA/INDs, and post-approval submissions.
• Experience supporting biologics and combination products preferred.
• Experience engaging with FDA or other regulatory authorities preferred.
• Ability to assess regulatory impact, support compliance activities, and mentor junior staff.
• Strong communication, negotiation, strategic thinking, problem-solving, prioritization, and cross-functional collaboration skills.
• Ability to support training activities and proactively address technical or regulatory knowledge gaps.

Pay

Salary Range (annually): $108,000.00 - $176,000.00