Telix Pharmaceuticals (AMER)

Sr. Manager, Global Regulatory Strategy

Canada · Senior

Sponsorship not specifiedDetected 28 days ago

Project ManagementFDA RegulatoryLeadershipCommunicationCollaborationAdaptabilityOrganizational SkillsRegulatory Affairs

About the role

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
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.
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.

Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
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.
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.
Support the development and execution of regulatory strategies for assigned portfolio assets, ensuring alignment with program objectives and global regulatory requirements
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.
Coordinate with regional stakeholders to support execution of global regulatory strategies at the regional level.

Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
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
Proven experience with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE)

Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Telix Pharmaceuticals is an equal opportunity employer.

We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

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.
Prior experience contributing to health authority interactions (briefing support, responses, documentation)

This listing is sourced directly from Telix Pharmaceuticals (AMER)'s careers page and normalized into a canonical job model.