Senior Manager, Global Regulatory Strategy

Responsibilities

• Support the development and execution of regulatory strategies for assigned portfolio assets, ensuring alignment with program objectives and global regulatory requirements
• Contribute to regulatory planning for new product development, global submissions, and lifecycle management activities across pipeline and commercial assets
• Partner cross-functionally to help align regulatory strategies with clinical, CMC, and commercial plans
• Maintain awareness of global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE) and apply them to program-level strategy and execution
• Identify regulatory risks and support development of mitigation plans in collaboration with senior regulatory leadership
• Lead the preparation for Health Authority interactions and submissions, including preparation of briefing documents, dossiers and other documentation in alignment with regulatory requirements
• Manage responses to Health Authority queries and support regulatory milestone deliverables
• Ensure documentation and communications are complete, accurate, and aligned with agreed regulatory strategies
• Serve as the regulatory lead on assigned R&D project teams and partner cross-functionally with Clinical, Quality, CMC, Commercial, non‑clinical and regulatory functions
• Provide input and recommendations on regulatory risks, opportunities, and implications across the global portfolio

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or related scientific field required
• 8+ years of experience within pharmaceuticals, biotech, or life sciences
• 5+ years of experience in Regulatory Affairs
• Strong background in regulatory strategy for oncology or radiopharmaceutical products is highly desirable
• Proven experience with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE)
• Prior experience contributing to health authority interactions (briefing support, responses, documentation)
• Experience working on cross-functional teams (Clinical, CMC, Quality, etc.)
• Solid understanding of drug development process and regulatory requirements across development and commercialization
• Ability to translate regulatory guidance into program-level actions
• Strong project management and organizational skills; able to manage multiple priorities
• Effective cross-functional collaboration and communication skills
• Ability to identify risks and elevate appropriately, with sound judgment.