Associate Director, Global Regulatory Strategy

🔥 13 hours ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Lead regulatory activities for clinical and commercial registrations across global markets • Manage overall regulatory oversight of the PSMA franchise, including new product development, registration approvals, and lifecycle management • Develop and implement regulatory strategies for INDs, NDAs, MAAs, and other regulatory filings • Manage the PSMA portfolio team, aligning workloads, business objectives, and timelines • Lead registration strategies and processes in collaboration with cross-functional teams • Act as regulatory lead for the PSMA portfolio across global regulatory frameworks • Provide regulatory risk assessments and mitigation plans • Communicate with applicants and health authorities including FDA, EMA, TGA Australia, CDE China, PMDA Japan, and other local authorities • Interface with QA, Clinical Development, Research and Innovation, and other functions to ensure timely, compliant dossiers • Lead regulatory portfolio planning and prioritization • Advise senior management on regulatory risks and opportunities • Collaborate with Commercial, Supply Chain, Quality, and Strategic teams • Manage responses to health authority queries, variations, and post-market compliance requirements

🎯 Requirements

• Degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred) • 15+ years of experience in Regulatory Affairs, including leadership • Strong experience in clinical and commercial regulatory submissions, including CTAs, INDs, NDAs, MAAs, and post-market variations • Expertise in global regulatory frameworks, including FDA, EMA, TGA, PMDA, Health Canada, and Medsafe • Proven ability to interact with regulatory agencies and lead successful health authority interactions • Strong knowledge of ICH guidelines, CTD/eCTD submissions, and regulatory lifecycle management • Ability to develop and implement global regulatory strategies • Ability to manage cross-functional and regional teams • Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities

🏖️ Benefits

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