Global Regulatory Strategy Manager

Job Summary

Supporting the international roll-out of approved oncology products, the full-time salaried Global Regulatory Strategy Manager will manage regulatory strategies for global development and commercialization programs, ensuring alignment with broader objectives while collaborating cross-functionally.

Key responsibilities:

• Support the development and execution of regulatory strategies for assigned portfolio assets, aligning with global regulatory requirements
• Lead the preparation for Health Authority interactions and submissions, ensuring documentation aligns with regulatory strategies
• Serve as the regulatory lead on R&D project teams, coordinating with cross-functional stakeholders to integrate regulatory considerations into development plans

Required qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a 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 contributing to health authority interactions