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
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