Head of Regulatory Affairs

Head of Regulatory Affairs
Location: Hybrid | New York, NY

About the Role

A venture-backed, clinical-stage oncology company advancing a differentiated pipeline of targeted radiotherapies across solid tumors and hematologic malignancies is seeking a Senior Director, Head of Regulatory Affairs.

This high-visibility leadership role will define and execute global regulatory strategy across early- and late-stage programs, partnering closely with Clinical, CMC, Medical, and Executive leadership to drive successful outcomes from IND through BLA.

Key Responsibilities

• Lead global regulatory strategy across IND through BLA

• Serve as primary regulatory lead in FDA, EMA, and global authority interactions

• Oversee preparation of INDs, briefing packages, protocols, BLAs, and expedited designations

• Identify regulatory risks and implement mitigation strategies

• Provide regulatory oversight across clinical, preclinical, and CMC activities

• Support accelerated pathways, orphan programs, and innovative trial designs

• Present regulatory strategy and risk assessments to executive leadership

Qualifications

• MS, PhD, or MD in Life/Health Sciences

• 15+ years biotech/pharma experience, including 10+ years in Regulatory Affairs

• Expertise in solid tumor oncology, biologics, and radiopharmaceuticals

• Demonstrated IND and BLA submission leadership

• Strong knowledge of U.S. and global regulatory frameworks

• Experience with accelerated and orphan pathways

• Proven success leading regulatory authority interactions