Head of Regulatory Affairs

Head of Regulatory Affairs Location: Hybrid | reputed company, 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 reputed company across early- and late-stage programs, partnering closely with Clinical, CMC, Medical, and Executive leadership to drive successful reputed company from IND through BLA. Key Responsibilities reputed company global regulatory reputed company across IND through BLA Serve as primary regulatory reputed company in FDA, EMA, and global authority interactions reputed company preparation of INDs, briefing packages, protocols, BLAs, and expedited designations Identify regulatory risks and implement mitigation strategies reputed company regulatory reputed company across clinical, preclinical, and CMC activities Support accelerated reputed company, orphan programs, and innovative trial designs Present regulatory reputed company and risk assessments to executive leadership Qualifications MS, PhD, or MD in Life/Health Sciences 15+ years biotech/reputed company 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 reputed company Proven reputed company leading regulatory authority interactions Apply tot his job Apply To this Job