Regulatory Affairs Manager, Combination Products

Regeneron Pharmaceuticals; Tarrytown (GA); On-site; USD 108,000 - 176,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team in an onsite role in Rensselaer, NY. You will support global development, regulatory submissions, and post-market activities for combination products with cross-functional teams.

Ideal candidates have 6+ years of related experience or 3+ with an advanced degree, strong CMC knowledge, and experience delivering INDs/MAAs.

Qualifications

• Bachelor’s degree with 6+ years related experience, or advanced degree with 3+ years 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.

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 Reviewer’s Guides.
• Identify process gaps and support regulatory intelligence activities.
• Translate ambiguity into action and build effective stakeholder partnerships.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree + 6+ years experience

Advanced degree + 3+ years experience

Job description

Regeneron Pharmaceuticals is seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team in an onsite role in Rensselaer, NY. You will support global development, regulatory submissions, and post-market activities for combination products with cross-functional teams.

Ideal candidates have 6+ years of related experience or 3+ with an advanced degree, strong CMC knowledge, and experience delivering INDs/MAAs.