Global Regulatory Strategy Manager

Job Summary

Supporting the international roll-out of approved prostate cancer imaging agents, the full-time salaried Global Regulatory Strategy Manager will manage regulatory strategies for global development and commercialization programs, ensuring alignment with broader development objectives.

Key responsibilities:

• Support the development and execution of regulatory strategies for assigned portfolio assets, ensuring alignment with program objectives and global regulatory requirements
• Lead the preparation for Health Authority interactions and submissions, managing responses to queries and ensuring documentation accuracy
• Serve as the regulatory lead on assigned R&D project teams, collaborating cross-functionally to integrate regulatory considerations into development and commercialization plans

Required qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or related scientific field; advanced degree preferred
• 8+ years of experience within pharmaceuticals, biotech, or life sciences, with 5+ years in Regulatory Affairs
• Strong background in regulatory strategy for oncology or radiopharmaceutical products
• Proven experience with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE)
• Experience working on cross-functional teams and a solid understanding of the drug development process