Associate Director, Global Regulatory Strategy

🔥 0 minutes ago

🌐 Canada, United States – Remote

🇨🇦 Canada – Remote 🇺🇸 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

• Lead regulatory activities for clinical and commercial registrations across global markets • Manage the PSMA franchise regulatory portfolio, including new product development, registration approvals, and lifecycle management • Develop and implement regulatory strategies for clinical, commercial, and lifecycle-management submissions • Plan submissions for INDs, NDAs, MAAs, and other relevant regulatory filings with cross-functional teams • Manage the PSMA portfolio team, including workload distribution and timeline adherence • Lead registration strategies and registration processes for the PSMA franchise • Act as regulatory lead for the PSMA portfolio, aligning activities with global regulatory frameworks • Provide regulatory risk assessments and mitigation plans • Prepare and present strategies to regulatory authorities and communicate with applicants and health authorities • Collaborate with QA, Clinical Development, Research and Innovation, Commercial, Supply Chain, Quality, and Strategic teams • Lead regulatory portfolio planning and prioritization • Advise senior management on regulatory risks and opportunities • Manage responses to Health Authority queries, variations, and post-market compliance requirements • Support the Senior Director, Global Regulatory Strategy, with global regulatory projects and strategic initiatives

🎯 Requirements

• Degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred) • 9+ 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 communicate effectively with colleagues and stakeholders at all levels • Ability to collaborate effectively as part of a team • Adaptability in a dynamic environment and willingness to take on new challenges • Commitment to ethical behavior and continuous professional development

🏖️ Benefits

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

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