Regulatory Affairs Manager, Combination Products – Onsite

Regeneron Pharmaceuticals, Inc.; Warren (MI); On-site; USD 108,000 - 176,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, v

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team in an onsite capacity.

You will support global combination product development, regulatory submissions, and post-market activities while collaborating with Regulatory Affairs, Manufacturing, Quality, and stakeholders. The role emphasizes US and global regulatory requirements for combination products, with experience in INDs/BLAs, human factors, and post-approval

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.
• 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.

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

Communication skills

Negotiation

Strategic thinking

Problem solving

Cross-functional collaboration

Education

Bachelor's degree with 6+ years related experience

Advanced degree with 3+ years related experience

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team in an onsite capacity.

You will support global combination product development, regulatory submissions, and post-market activities while collaborating with Regulatory Affairs, Manufacturing, Quality, and stakeholders. The role emphasizes US and global regulatory requirements for combination products, with experience in INDs/BLAs, human factors, and post-approval