Manager Combination Products - Regulatory Affairs
Regeneron Pharmaceuticals
Summary
Support global combination product development, regulatory submissions, and post-market activities while collaborating with Regulatory Affairs, Manufacturing, Quality, and combination product stakeholders.
Job description
Discover your role
- 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.
Requirements
- 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.
- 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.
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, Dental & Vision
- Life and disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.