Associate Director, Global Regulatory Strategy

Role: Associate Director, Global Regulatory Affairs at Telix Pharmaceuticals, responsible for leading regulatory activities for the PSMA radiopharmaceutical franchise across global markets. Key objectives include developing and implementing regulatory strategies for clinical trials, product registration (INDs, NDAs, MAAs), and lifecycle management, ensuring global compliance and facilitating market access. Responsibilities encompass managing regulatory submissions, maintaining communication with authorities (FDA, EMA, TGA, PMDA), leading portfolio planning, and supporting cross-functional teams such as Clinical Development, QA, and Commercial. The role also involves risk assessment, response management to health authority queries, and strategic alignment of regulatory activities. Qualifications: Bachelor’s degree in Life Sciences, Pharmacy, or related field; 15+ years in Regulatory Affairs with leadership experience; proven expertise in global regulatory frameworks, submissions, and agency interactions. Preferred: Advanced degree and extensive experience with radiopharmaceuticals or oncology therapeutics, particularly in late-stage clinical or post-market stages. High-value specifics include managing the PSMA imaging agent, a precision radiopharmaceutical targeting prostate cancer, with involvement in clinical development, registration, and lifecycle management. Collaboration spans multiple regions and functions, with a hybrid/remote work setup and potential global travel.