Senior Director, GMP Counsel Regulatory
ACC San Diego - Association of Corporate Counsel · Rensselaer, NY · 1 mo ago
LegalFull-time
Job Summary
The Senior Director, GMP Counsel Regulatory provides legal advice and counsel to global manufacturing operations regarding GMP-related matters in Regeneron’s manufacturing, quality, and supply chain operations.
About the role
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.
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.
- Advises internal stakeholders on legal regulatory risk, strategy, and compliance considerations related to GMP manufacturing operations and, as applicable, remediation and recall activity.
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.