Job Description Summary
The Senior Director of Regulatory Affairs, Radiopharma serves as a senior global leader within the Pharmaceutical Diagnostics (PDx) Regulatory Affairs organization, reporting into the Global Head of Regulatory Affairs. This role provides end to end regulatory leadership across drug development, registration, lifecycle management, compliance, and CMC for key markets including the United States, while supporting global regulatory strategy, governance, and operational excellence. The Senior Director leads a multi regional team of global regulatory professionals and partners closely with regulatory regional teams and the cross functional leaders to advance the PDx product portfolio efficiently and compliantly.
Job Description
Key Responsibilities
- Global Regulatory Strategy & Execution
- Develop, oversee and drive global regulatory strategies for assigned development programs and marketed products in US, and other priority markets supported by the regional regulatory teams, ensuring alignment with business objectives, regional requirements,



and long‐term portfolio plans.
- Provide strategic guidance from early development to registration and lifecycle, leveraging expertise across CMC, non‐clinical, clinical, and quality domains.
- Monitor and interpret global regulatory trends, emerging guidances, and agency expectations to inform program design and risk mitigation strategies.
- Health Authority Engagement & Advocacy
- Serve as the senior regulatory lead in interactions with major health agencies including FDA, leading high‐stakes negotiations and ensuring high‐quality briefing packages and responses.
- Represent the organization in global regulatory forums and external industry groups to influence evolving regulations and advocate for PDx‐relevant policy positions.
- Cross‐Functional & Global Program Leadership
- Partner with R&D;, CMC, Manufacturing, Clinical, Medical, Quality, Commercial, and Supply Chain teams to integrate regulatory requirem

📌 Senior Director, Regulatory Affairs, Radiopharma (Italia)
🏢 Ge Healthcare
📍 Italia