Executive Director, Regulatory Affairs - Cell Medicine

Company: Regeneron Pharmaceuticals, Inc
Location: Cambridge
Posted on: June 2, 2025

Job Description:

In this key leadership role, you will build and oversee the Global Regulatory Science and Regulatory CMC strategic framework and support driving deliverables for the Regeneron Cell Medicines, based in Cambridge, MA. This business unit focuses on advancing cellular therapeutics in hematologic and solid tumors, autoimmunity, and developing novel conditioning/lymphodepletion options for cell therapy and stem cell transplant.You will build and lead a cell medicine regulatory affairs team, providing regulatory leadership and oversight for innovative regulatory strategies, including guidance and the preparation and submission of high-quality INDs, CTAs, and marketing applications (BLAs/MAAs). You will also interact with health authorities.This role involves leading in a cross-functional, multicultural environment, leveraging extensive experience to represent regulatory affairs in discussions with stakeholders.A typical day might include:

• Providing strategic guidance on FDA and global regulatory requirements for investigational and commercial products.
• Developing and maintaining health authority engagement strategies and interaction plans.
• Building, leading, and mentoring the regulatory team, offering strategic guidance to expedite product development and lifecycle management.
• Overseeing the preparation of CMC regulatory submissions and supporting interactions with regulatory authorities to secure approvals.
• Applying knowledge of clinical development regulatory aspects, including IND and NDA processes.
• Advising on the development of new regulatory requirements or guidance documents.
• Providing regulatory review and perspective on business development opportunities.This role might be suitable if you have:

• Experience in Cell & Gene Therapy and regulatory expedited development pathways.
• Excellent communication and presentation skills.
• Experience supporting development programs and marketed products.
• Prior experience with IND & BLA submissions (strongly preferred).
• Management experience in regulatory staff and budgets.
• Pharm.D, M.D., or Ph.D. in related fields.
• 15+ years in the pharmaceutical or biotech industry, with at least 10 years in Regulatory Science CMC for biologics or 4+ years in Cell & Gene Therapy / ATMPs.Does this sound like you? Apply now to begin your journey with Regeneron! We offer an inclusive, diverse culture with benefits such as health programs, fitness centers, equity awards, bonuses, and paid time off.Regeneron is an equal opportunity employer, considering all qualified applicants without discrimination based on race, gender, age, disability, or other protected characteristics. We also provide reasonable accommodations for known disabilities or chronic illnesses.For U.S.-based roles, salary ranges are as specified; for Japan and Canada, they follow local laws and currencies. If outside these countries, please consult with your recruiter regarding salaries and benefits.Note: Background checks are part of the recruitment process, conducted according to local laws, to verify identity, right to work, educational qualifications, etc.Salary Range (annually): $251,200.00 - $418,600.00
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Keywords: Regeneron Pharmaceuticals, Inc, Peabody , Executive Director, Regulatory Affairs - Cell Medicine, Executive , Cambridge, Massachusetts