Senior Director, Global Regulatory Lead

Objective

Reporting to the Senior Vice President, Global Regulatory Affairs, the Senior Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership across radiopharmaceutical clinical development programs and future commercial launches. This role is responsible for the development and execution of global regulatory strategies, as well as for leading global regulatory submissions in support of clinical development, product registrations, and lifecycle management activities.

As the primary regulatory strategic advisor and a core member of cross‑functional development teams, the Senior Director and GRL translates complex and evolving global regulatory requirements into clear, actionable strategies that enable efficient decision‑making and timely execution. The role ensures regulatory alignment across functions, drives key regulatory deliverables, and supports the successful advancement of radiopharmaceutical programs from early development through commercialization in a dynamic regulatory landscape.

Leadership

• Serve as the single point of accountability for the execution of global regulatory strategy for assigned development programs.
• Develop, maintain, and continuously refine a forward‑looking global regulatory roadmap, integrating companion diagnostic considerations (as applicable), clinical development, CMC/radiochemistry, non‑clinical strategy, quality, manufacturing readiness, and full lifecycle planning.
• Shape and advance innovative global regulatory pathways, including the strategic use of expedited programs, dose and regimen optimization frameworks, incorporation of radiopharmaceutical‑specific guidance, and intentional sequencing of regulatory interactions and scientific advice.
• Drive global regulatory strategy across the entire product lifecycle, including initial approvals, post‑marketing commitments, pediatric development, label expansion, and global market expansion.
• Lead, mentor, and develop Global Regulatory Affairs (GRA) team members, while providing strong matrix leadership across global regulatory contributors and cross‑functional partners.

Program Leadership & Collaboration

• Oversee the planning, authoring, execution, and approval of major global regulatory submissions and health authority interactions for radiopharmaceutical products, including:
  • IND, CTA, and CTIS submissions
  • Expedited regulatory programs and special designations (e.g., Fast Track, Breakthrough Therapy, PRIME, Orphan Drug Designation)
  • Formal regulatory milestone meetings and scientific advice interactions across development phases
  • NDA and MAA submissions
  • Pediatric plans (iPSP, PIP), IND amendments, and periodic safety updates
• Ensure regulatory submissions are scientifically robust, strategically aligned, and compliant with global regulatory expectations, with particular attention to the unique requirements of radiopharmaceuticals (e.g., manufacturing controls, isotope supply, dosimetry, and integrated safety considerations).
• Lead and coordinate responses to global regulatory inquiries and health authority questions, ensuring scientific rigor, regulatory consistency, and alignment with overall program strategy.

Health Authority Engagement

• Lead the regulatory strategy, content development, and execution for interactions with global health authorities, ensuring integrated, consistent, and scientifically aligned messaging across clinical, CMC/radiochemistry, non‑clinical, dosimetry, and safety topics.
• Drive global regulatory alignment through parallel or coordinated engagement strategies, including joint or sequential scientific advice and milestone interactions with multiple health authorities.
• Serve as a senior regulatory representative and spokesperson for the company in…