Global Regulatory Head

Global Regulatory Head Position Summary The Global Regulatory Head directs the regulatory strategy and submissions for the company's RLT portfolio, ensuring compliance with international standards for radiopharmaceuticals. This strategic role owns briefing books, IND/CTAs/amendments, and overall regulatory planning to facilitate timely approvals. Reporting to the CMO or VP of Regulatory Affairs, it requires deep knowledge of global regulations for radioactive drugs, bridging clinical development with health authorities. Key Responsibilities Briefing Books Ownership: Author and compile briefing books for regulatory meetings (e.g., FDA Type B/C, EMA scientific advice), incorporating RLT data on safety, efficacy, and manufacturing. IND/CTA/Amendments Management: Lead the preparation, submission, and maintenance of INDs, CTAs, and amendments, addressing RLT-specific elements like CMC for radionuclides and dosimetry justifications. Regulatory Strategy Development: Formulate global regulatory strategies, including accelerated pathways (e.g., Breakthrough Therapy Designation) for RLT assets in oncology. Health Authority Interactions: Represent the company in interactions with FDA, EMA, PMDA, and other agencies, preparing responses to queries on RLT topics. Compliance Oversight: Ensure all submissions comply with ICH, GMP, and radiation-specific regulations (e.g., 21 CFR Part 212 for PET drugs). Cross-Functional Integration: Collaborate with clinical, CMC, and quality teams to align