Manager Combination Products - Regulatory Affairs

Build our future together: 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. In this role, you will support global combination product development, regulatory submissions, and post-market activities while collaborating with Regulatory Affairs, Manufacturing, Quality, and combination product stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide . When & where: Rensselaer, New York Work model: Onsite, 5 days per week 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. • You translate ambiguity into action and build effective stakeholder partnerships. This role requires: • 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. We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(