Senior Manager, Global Regulatory Strategy

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Oversee regulatory activities for assigned early-stage portfolio across global markets • Execute global regulatory strategy for assigned assets • Plan and deliver submissions from IND/CTA through early registration • Provide regulatory expertise for early-stage programs • Prepare health authority interactions • Support the VP, Global Regulatory Strategy, on global regulatory planning and cross-functional initiatives • Develop submission plans, timelines, and content requirements • Support registration strategies and manage registration processes • Prepare briefing packages and supporting materials for health authority meetings • Draft meeting minutes and responses to agency questions • Interface with FDA, EMA, TGA, PMDA, and other health authorities • Partner with QA, Clinical Development, Research & Innovation, and other functions to assemble compliant, on-time dossiers • Provide regulatory guidance to project teams • Identify regulatory risks and recommend mitigation plans • Monitor evolving global health authority regulations and guidelines • Manage responses to health authority queries, variations, and post-approval requirements

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred) • 8+ years of experience in Regulatory Affairs, with strong early-stage (IND/CTA) submission experience • Strong experience in clinical regulatory submissions (CTAs, INDs) and early-stage development • Working knowledge of global regulatory frameworks (FDA, EMA, TGA, PMDA, Health Canada, Medsafe) • Experience preparing for and supporting health authority interactions • Strong knowledge of ICH guidelines and CTD/eCTD submissions • Knowledge of the regulatory lifecycle • Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities

🏖️ Benefits

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