National Employee Health and Benefits Compliance Consultant
Marsh McLennanAdvise Marsh McLennan Agency clients on U.S. employee health and benefits compliance. Support compliance education, training, research, and client presentations.
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Regeneron is a biotechnology company that discovers, develops, and commercializes medicines for serious and underserved conditions. Its research spans allergy, cardiovascular and metabolic disease, neuroscience, oncology, hematology, ophthalmology, and rare diseases. By combining biological research with advanced technology, Regeneron works on biologics and genetic medicines designed to address complex healthcare needs. The company also highlights health equity, environmental responsibility, scientific education, and ethical corporate practices as part of its broader mission to advance patient care.
CMC Regulatory Affairs Manager — Regeneron (Hybrid)
Manage CMC regulatory strategy for biologics at Regeneron, supporting development, submissions, and compliance. Coordinate global strategies and health authority interactions for medicines.
United States
New Jersey$108,000 – $176,000 / year
HybridFull-timeMiddleSeniorEnglish RequiredComplianceDescription
- Lead CMC regulatory strategies for assigned biologic products
- Support CMC development from early stages through submissions and post-market activities
- Evaluate changes and deviations for regulatory impact and filing needs
- Review regulatory submissions for alignment with applicable regulations and guidance
- Assist with health authority engagement, including meetings and responses to information requests
- Create work instructions, SOPs, and reviewer guides to promote consistent practices
- Spot regulatory process gaps and propose ways to improve efficiency
- Turn unclear issues into practical next steps and build agreement across teams
- Work with Global Regulatory Affairs and CMC partners
- Contribute to training and help address technical or regulatory knowledge gaps
Requirements
- Bachelor’s degree plus at least 6 years of experience, or an advanced degree plus at least 3 years, in pharmaceutical, biotechnology, or health authority settings
- 2–4 years of CMC Regulatory Affairs experience involving regulations worldwide
- Strong knowledge of global CMC Regulatory Affairs requirements
- Experience preparing CMC sections for marketing authorizations, CTA/INDs, and post-approval submissions
- Experience supporting biologic products is preferred
- Experience working with the FDA or other regulatory authorities is preferred
- Strong communication, negotiation, strategic thinking, and problem-solving abilities
- Ability to build cross-functional partnerships, balance competing priorities, and deliver results in changing environments
- Ability to contribute to training and proactively address technical or regulatory knowledge gaps
- Background screening may include identity, work authorization, and education verification
Benefits
- Annual bonuses or other incentive programs
- Equity awards
- Pension or retirement benefits
- Company matching contributions to a 401(k)
- Health and wellness programs
- On-site fitness centers
- Medical, dental, vision, life, and disability insurance
- Paid leave
- Family support programs
- Reasonable accommodations during recruitment where required
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