💼 About This Role

You'll lead regulatory strategy for in vivo CAR-T therapy programs at an industry-leading biotech. You'll drive IND/CTA/BLA submissions and interact with global health authorities. This role offers the chance to shape cutting-edge cell therapy development.

🎯 What You'll Do

• Develop global regulatory strategies for in vivo CAR-T programs
• Lead IND/CTA/BLA/MAA submissions and health authority interactions
• Collaborate with cross-functional teams on study design and endpoints
• Communicate regulatory strategy and risks to senior management

📋 Requirements

• PhD with 12+ years or MS with 15+ years or BS with 15+ years in regulatory affairs
• Experience in oncology or hematology drug development
• Successful track record of regulatory submissions and approvals
• Expertise in cell gene therapy, preferably CAR-T

✨ Nice to Have

• Experience with in vivo gene delivery
• Executive Director level qualifications (PhD with 15+ years)

🚩 Heads Up

• Role may be leveled as Senior Director or Executive Director based on qualifications, causing ambiguity in responsibility
• Travel required (~20%), which may be excessive for some candidates