Senior Manager, Global Regulatory Strategy

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Telix Pharmaceuticals Limited

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2015

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Telix Pharmaceuticals Limited est une entreprise biopharmaceutique en phase commerciale dédiée à transformer la manière dont les cancers et les maladies rares sont diagnostiqués et traités. En se concentrant sur le développement et la commercialisation de radiopharmaceutiques théranostiques, Telix utilise la radiation ciblée pour améliorer la prise de décisions thérapeutiques et fournir des thérapies personnalisées. Avec un vaste portefeuille dans des domaines tels que le cancer de la prostate et du rein, la neuro-oncologie et les cancers musculo-squelettiques, Telix a obtenu des approbations réglementaires mondiales pour son principal agent d'imagerie, Illuccix®, et mène activement de nombreux essais cliniques à travers le monde.

Description

• 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

🎯 Exigences

• 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 escalate appropriately, with sound judgment.

🏖️ Avantages

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development