Senior Director, Global Regulatory Lead

Role: Lead global regulatory strategy for radiopharmaceutical clinical development programs and future commercial launches, ensuring compliance and alignment across development phases. Responsibilities: develop and execute regulatory strategies, oversee global submissions (INDs, CTAs, NDAs, MAAs), manage health authority interactions, and shape innovative regulatory pathways, including expedited programs and radiopharmaceutical-specific guidance. Lead, mentor, and coordinate cross-functional teams including clinical, CMC, non-clinical, and safety, ensuring regulatory alignment across the product lifecycle from early development to commercialization. Maintain deep expertise in radiopharmaceutical regulations, dosimetry, manufacturing controls, and safety considerations, translating regulatory intelligence into strategic insights. Oversee the preparation and review of high-quality regulatory documentation, partner with external vendors, and lead responses to authority inquiries. Requirements: Bachelor's in science or related field; advanced degree preferred; 10+ years of regulatory experience in oncology, complex modalities, or radiopharmaceuticals; proven success in global submissions and authority engagement; RAC certification is a plus. HighValue: Radiopharmaceuticals, oncology, complex drug modalities, clinical and late-stage development, regulatory submissions, global health authority interactions, and lifecycle management. WorkSetup: remote/home-based with up to 20% travel.