What are the responsibilities and job description for the Senior Director, GMP Counsel Regulatory position at ACC - Oregon Chapter?
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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.
When & Where
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.
When & Where
- Work Location: Rensselaer, NY
- Hybrid: 4.5 days per week on site
- 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.
- 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.