Senior Director, Global Regulatory Affairs

Job Summary

Providing strategic regulatory leadership for radiopharmaceutical clinical development programs, the full-time Senior Director, Global Regulatory Affairs will manage global regulatory strategies, oversee major submissions, and engage with health authorities in a remote work environment.

Key responsibilities

• Develop and execute global regulatory strategies for clinical development and commercial launches
• Lead and coordinate major global regulatory submissions, ensuring compliance and strategic alignment
• Engage with global health authorities to foster constructive regulatory relationships and ensure consistent messaging

Required qualifications

• Bachelor's degree in a scientific or life sciences discipline; advanced degree (M.S. or Ph.D.) preferred
• Minimum of 10 years of progressive Regulatory Affairs experience in oncology or complex modalities
• Proven track record of leading global regulatory submissions and approvals, including INDs and marketing applications
• Extensive experience engaging with global health authorities, particularly in oncology development
• Strong understanding of global regulatory requirements applicable to oncology and complex therapeutic modalities