Senior Director, Clinical Regulatory Affairs

Responsibilities

• Provide regulatory leadership for in vivo CAR-T therapy programs
• Develop global regulatory strategies to support clinical trial design and indication selection
• Lead global submissions (IND/CTA/BLA/MAA) and strategy for registration documents
• Act as primary contact for global regulatory agencies regarding program advancement
• Communicate the regulatory strategy and risks to internal and external stakeholders
• Identify and propose solutions for complex regulatory issues
• Collaborate with multidisciplinary teams to align on strategy and advancements

Qualifications

• 12-15+ years of regulatory affairs experience (Senior Director) or 15-18+ years (Executive Director) in relevant scientific field required
• Experience preferred in Oncology, Hematology, or similar specialties with a track record of successful regulatory submissions
• Demonstrated expertise in cell & gene therapy, especially CAR-T or T-cell modalities
• Strong knowledge of global regulatory requirements for gene and cell therapies
• Proven ability to interact effectively with regulatory authorities
• Excellent communication and leadership skills, with a focus on cross-functional collaboration
• Passion for innovation in transformative therapies

Benefits

• Competitive Medical, Dental, and Vision plans
• 401k plan with a 100% match up to the first 4% deferral
• Generous Paid Time Off policy
• Employee commuter benefits
• Cell phone stipend