仕事内容
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 have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)