Senior Director, GMP Counsel Regulatory

Regeneron Pharmaceuticals

6d • Onsite

About The Position

The Senior Director, GMP Counsel Regulatory provides legal advice and counsel to global manufacturing operations (including Quality Assurance, Quality Control and other IOPS leadership) regarding GMP-related matters in Regeneron’s manufacturing, quality, and supply chain operations that constitute Regeneron’s Industrial Operations and Product Supply (“IOPS”) organization. This role serves as a subject matter expert and key advisor on U.S. and global GMP legal and regulatory requirements, supporting GMP compliance across manufacturing, development, clinical, and commercial programs. The Senior Director partners closely with Quality (including Data Integrity), Manufacturing, Technical Operations (including Automation), IT (including AI), Supply Chain, Regulatory and other Law Department colleagues to support inspections, filings, and ongoing inspection readiness.

Requirements

• JD required with significant experience in pharmaceutical, biotechnology, or highly regulated environment.
• 15+ years of progressive regulatory affairs legal counsel or related government (or industry) experience with significant GMP exposure.
• 5+ years of demonstrated experience supporting FDA and/or global regulatory inspections, 483 response and corrective actions/remediation, recall and other regulatory significant activity.

Nice To Haves

• Excellent oral and written communication skills with proven ability to present complex information accurately and concisely
• Strong interpersonal communication skills and an ability to build trust and influence at all levels
• Ability to handle multiple priorities in a dynamic and evolving environment
• Strategic thinker with excellent analytical and problem-solving skills, focusing on practical solutions

Responsibilities

• Interpret and advise on GMP regulations to inform strategy and execution for manufacturing and quality-related regulatory activities throughout IOPS.
• Counsel and apply U.S. and global GMP law regulations to business operations.
• Serve as primary legal counsel on GMP compliance matters impacting development, clinical and commercial manufacturing across all operations - - bulk/API, fill-finish/packaging, etc.
• Advise and support preparation, management, and response activities for regulatory GMP inspections and partner/collaborator audits.
• Provide legal guidance on regulatory GMP inspection findings, CAPAs, remediation strategies, and enforcement risk mitigation.
• Partner with IOPS key functions (e.g., QA, Manufacturing and Automation, IT) to ensure continuous inspection readiness.
• Collaborate with QA, Manufacturing and Automation, IT, Supply Chain, Technical Operations, Regulatory and Law teams.
• Advise internal stakeholders on legal regulatory risk, strategy, and compliance considerations related to GMP manufacturing operations and, as applicable, remediation and recall activity.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree