Telix Pharmaceuticals
Radiopharmaceutical
Sr.Manager,GlobalRegulatoryStrategy
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“Sr. Manager, Global Regulatory Strategy at Telix Pharmaceuticals. Skills: Regulatory strategy, Global regulatory, Health authority engagement, Risk management. Support development of regulatory strategies. Support execution of regulatory strategies”
What You'll Achieve.
Advance portfolio of products; Optimize timelines; Optimize risk management; Optimize market access outcomes; Deliver regulatory milestones
Industry & Context.
Risk identification; Risk mitigation
What They're Looking For.
Must Have
5+ years experience, Global regulatory frameworks awareness
Nice to Have
Experience with FDA, Experience with EMA, Experience with TGA, Experience with PMDA, Experience with CDE
What You'll Do.
Support development of regulatory strategies
Support execution of regulatory strategies
Align regulatory strategies with program objectives
Align regulatory strategies with global requirements
Contribute to regulatory planning
Support global submissions
Support lifecycle management
Align regulatory strategies with clinical plans
Align regulatory strategies with CMC plans
Align regulatory strategies with commercial plans
Maintain awareness of global regulatory frameworks
Apply regulatory frameworks to strategy
Apply regulatory frameworks to execution
Identify regulatory risks
Support development of mitigation plans
Assist in preparation for health authority interactions
Support optimization of timelines
Support optimization of risk management
Support optimization of market access outcomes
Collaborate cross-functionally
Support regulatory planning
Support regulatory execution
Provide input on regulatory risks
Provide input on regulatory considerations
Ensure consistent delivery of regulatory milestones
Ensure timely delivery of regulatory milestones
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Partner with senior leadership; Work with stakeholders
Communication Scope
Effective communication
Process & Methodology
Timeline optimization
Full Job Description
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix 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 d
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