Senior Director, GMP Counsel Regulatory

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.

A typical day may include:

• 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.

This role may be for you if you have:

• 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

To be considered for this role, you must have:

• 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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$203,000.00 - $338,400.00