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The Sr. Manager, Global Regulatory Strategy supports the Group's strategic objectives by contributing to the development and execution of regulatory strategies for global development and commercialization programs. This role partners with senior regulatory leadership to support regulatory planning across assigned programs, including development, registration, and lifecycle activities.

The Senior Manager is responsible for supporting global regulatory strategy execution across pipeline and/or marketed programs, ensuring alignment between regulatory activities and broader development and commercial objectives. This includes contributing to the evaluation of regulatory pathways, assisting in the preparation for health authority interactions, and supporting efforts to optimize timelines, risk management, and market access outcomes.

This role collaborates cross-functionally to support regulatory planning and execution, provides input on regulatory risks and considerations, and helps ensure consistent and timely delivery of regulatory milestones across assigned programs.

Key Accountabilities:

Regulatory Strategy and Planning

• • 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-functional 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.

Health Authority Engagement & Submissions

• • 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.

Cross-Functional Leadership & Influence

• • 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 to support integration of regulatory considerations into development and commercialization plans.
  • Participate in cross-functional teams to ensure alignment and timely execution of regulatory activities.
  • Provide input and recommendations on regulatory risks, opportunities, and implications across the global portfolio.
  • Coordinate with regional stakeholders to support execution of global regulatory strategies at the regional level.

Education and Experience:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or related scientific field required. Advanced degree (MS, PhD, PharmD) preferred.
• 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
• Experience in biologics is highly preferred
• 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 escalate appropriately, with sound judgment

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills