Manager Combination Products - Regulatory Affairs

Regeneron Pharmaceuticals • Rensselaer, IN

7d • $108,000 - $176,000 • Onsite

About The Position

Regeneron is seeking a Manager, Regulatory Affairs - Combination Products to join its Regulatory Affairs team and support the combination product business area. The role supports global combination product development, regulatory submissions, and post-market activities, collaborating with Regulatory Affairs, Manufacturing, Quality, and other combination product stakeholders. The position is onsite five days per week in Rensselaer, New York.

Requirements

• Bachelor’s degree with 6+ years of related experience, or an 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.
• Ability to assess regulatory impact and support compliance activities.
• 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.

Nice To Haves

• Experience supporting biologics and combination products.
• Experience engaging with the FDA or other regulatory authorities.

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.
• Build effective stakeholder partnerships and translate ambiguity into action.
• Support compliance activities and mentor junior staff.
• Support training activities and proactively address technical or regulatory knowledge gaps.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager