Senior Manager, Global Regulatory Strategy

🕒 Junho 11

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Telix Pharmaceuticals Limited

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2015

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Telix Pharmaceuticals Limited é uma empresa biofarmacêutica em estágio comercial dedicada a transformar a forma como o câncer e doenças raras são diagnosticados e tratados. Com foco no desenvolvimento e comercialização de radiofármacos teranósticos, a Telix utiliza radiação direcionada para aprimorar a tomada de decisões terapêuticas e oferecer uma terapia personalizada. Com um extenso pipeline que aborda áreas como câncer de próstata e rim, neuro-oncologia e cânceres musculoesqueléticos, a Telix obteve aprovações regulatórias globais para seu principal agente de imagem, o Illuccix®, e está conduzindo ativamente inúmeros ensaios clínicos em todo o mundo.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

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