Unknown Company

Senior Director, Clinical Regulatory Affairs

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co • Posted 2 weeks ago
Onsite Full Time Compliance & Regulatory Affairs

Responsibilities

  • Provide regulatory leadership and oversight for ongoing and planned in vivo CAR‑T therapy programs.
  • Develop and execute global regulatory strategies to support indication selection, trial design, and endpoints.
  • Develop registration strategies and plans to achieve regulatory approvals.
  • Lead global regulatory filings (IND/CTA/BLA/MAA submissions).
  • Serve as the primary point of contact with global regulatory agencies.
  • Communicate the regulatory strategy, risks, mitigations, and overall plans to various stakeholders.
  • Identify, communicate, and propose resolutions to routine and complex issues.
  • Provide regulatory advice and guidance to project teams.
  • Collaborate closely with various teams to align overall strategy with scientific discoveries.
  • Stay current on emerging trends, competitors, and regulatory guidance in applicable areas.
  • Work with external program partners collaboratively and effectively.

Requirements

  • PhD/MS/BS in a relevant scientific field required.
  • Minimum of 12/15/15+ years of relevant experience in regulatory affairs for Senior Director level.
  • Minimum of 15/18/18+ years of relevant experience in regulatory affairs for Executive Director level.
  • Experience in Oncology, Hematology, or related specialty strongly preferred.
  • Successful track record of regulatory submissions and approvals.
  • Demonstrated expertise in cell & gene therapy, ideally with CAR‑T or T-cell engaging modalities preferred.
  • Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies.
  • Proven ability to interact with regulatory authorities.
  • Excellent communication, leadership, and cross-functional collaboration skills.
  • Passion for innovation and commitment to advancing transformative therapies for patients.

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    Senior Director, Clinical Regulatory Affairs in co at Unknown Company

    This position is listed as full time and onsite.

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