Senior Director of Global Regulatory Affairs

Job Summary

Providing strategic regulatory leadership, the full-time Senior Director of Global Regulatory Affairs will develop and execute global regulatory strategies for radiopharmaceutical clinical development programs and commercial launches while working remotely.

Key responsibilities

• Lead the execution of global regulatory strategy and oversee major regulatory submissions for radiopharmaceutical products
• Engage with global health authorities to ensure consistent and scientifically aligned messaging across all regulatory interactions
• Maintain expertise in global regulatory frameworks and translate regulatory intelligence into actionable insights for development strategy

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 specialty therapeutics
• Proven track record of leading major global regulatory submissions, including INDs and marketing applications
• Extensive experience engaging with global health authorities, particularly in complex oncology development programs
• Strong understanding of regulatory requirements applicable to radiopharmaceuticals and complex therapeutic modalities