Description

You will shape global clinical regulatory strategy across Sana Biotechnology's pipeline, focusing on Type 1 diabetes, oncology, and autoimmune disease programs. You will develop and execute regulatory strategies from Phase 1 to commercialization, lead submissions and health authority interactions, and mentor junior staff.

Requirements

• Bachelor's degree required, advanced degree in relevant scientific field preferred
• 10+ years regulatory affairs experience in biopharmaceutical industry
• Demonstrated success in leading IND/CTA submissions, pivotal-stage amendments, BLA/MAAs
• Clinical-stage regulatory experience in Type 1 diabetes, oncology, or autoimmune disease preferred
• Strong understanding of FDA, EMA, and international guidelines

Responsibilities

• Direct clinical regulatory strategies for assigned programs in Type 1 diabetes, oncology, and autoimmune disease
• Create regulatory development plans including milestones, registration strategies, and health authority engagement plans
• Partner cross-functionally with Clinical Development, CMC Regulatory, Clinical Operations, Safety, Technical Operations, and Program Leadership
• Lead/oversee global regulatory submissions and health authority interactions
• Mentor junior regulatory staff