Executive Director, Regulatory Affairs - Cell Medicine - Regeneron Pharmaceuticals : Job Details

Executive Director, Regulatory Affairs - Cell Medicine

Regeneron Pharmaceuticals

Job Location : Cambridge,MA, USA

Posted on : 2025-08-09T01:03:25Z

Job Description :
Executive Director, Regulatory Affairs - Cell Medicine

In this key leadership role, you will build and oversee the Global Regulatory Science and Regulatory CMC strategic framework. You will support driving deliverables for Regeneron Cell Medicines, based in Cambridge, MA, a business unit focused 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 in developing innovative regulatory strategies, guidance, and managing the strategy, preparation, and submission of high-quality INDs, CTAs, and marketing applications (BLAs/MAAs), including interactions with health authorities.

This role requires leading in a cross-functional and multicultural environment, leveraging extensive experience to represent regulatory affairs in discussions with internal and external stakeholders.

Typical responsibilities include:
  • Providing strategic guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and commercial products.
  • Developing and maintaining health authority engagement strategies, interaction plans, and timelines, including the formulation of briefing documents with strategic and scientific content.
  • Building, leading, and mentoring the regulatory team, offering strategic guidance to expedite product development, registration, and lifecycle management.
  • Overseeing the Regulatory CMC function in preparing high-quality CMC regulatory submissions and supporting interactions with regulatory authorities to secure approvals.
  • Applying knowledge of clinical development regulations, including protocol development, data analysis, and regulatory submissions like INDs and NDAs.
  • Identifying new regulatory requirements or guidance documents and advising product teams on their impact.
  • Providing regulatory review and insights on business development opportunities.
    • Ideal candidates will have:
    • Experience in Cell & Gene Therapy, regulatory expedited development, and approval pathways (preferred).
    • Excellent communication, presentation, and interpersonal skills.
    • Experience supporting development programs and marketed products.
    • Prior experience with IND & BLA submissions (strongly preferred).
    • Experience managing regulatory staff and budgets.
    • Qualifications such as Pharm.D, M.D., or Ph.D. in relevant fields.
    • Typically, 15+ years of experience 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.

    If this sounds like you, apply now to join Regeneron! We offer an inclusive, diverse culture with comprehensive benefits, including health programs, fitness centers, equity awards, bonuses, and paid time off.

    Regeneron is an equal opportunity employer committed to diversity and inclusion. We provide reasonable accommodations for applicants with disabilities.

    Note: Salary ranges are provided in accordance with local laws applicable to the candidate's location.

    Salary Range (annually): $251,200.00 - $418,600.00

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