Senior Director, Clinical 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.

• 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.