Telix Pharmaceuticals

Radiopharmaceutical

Sr.Manager,GlobalRegulatoryStrategy

CA$165–235k ~AI est. Canada Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Sr. Manager, Global Regulatory Strategy at Telix Pharmaceuticals. Skills: Regulatory strategy, Global submissions, Lifecycle management. Support development of regulatory strategies. Execute regulatory strategies”

What You'll Achieve.

Optimize timelines; Optimize risk management; Optimize market access outcomes; Ensure timely delivery of milestones

Industry & Context.

Radiopharmaceutical
Problems you'll solve

Risk assessment; Problem solving

What They're Looking For.

Must Have

5+ years experience, Global regulatory requirements

Nice to Have

Experience with CDE, Experience with PMDA, Experience with TGA, Experience with EMA, Experience with FDA

What You'll Do.

Support development of regulatory strategies

Execute 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

Manage multiple priorities

Escalate risks appropriately

How You'll Work.

Team & Collaboration

Cross-functional collaboration; Partner cross-functional

Communication Scope

Cross-functional communication; Stakeholder 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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