Manager, Regulatory Affairs (Clinical Labeling)

Role: Manager, Regulatory Affairs (Clinical Labeling) at Telix Pharmaceuticals, responsible for developing, maintaining, and overseeing IMP (investigational medicinal product) labeling for global clinical trials, ensuring compliance with international regulatory standards. Responsibilities include creating, reviewing, and updating labeling documents, coordinating with internal teams and external vendors, managing translation and artwork approval, and supporting regulatory submissions and inspections. The role supports IMP lifecycle management and adapts labeling to evolving regulations across regions, including US, EU, UK, Australia, and Asia-Pacific. Qualifications: Bachelor's in life sciences, minimum 5 years in pharmaceutical regulatory affairs or clinical operations, with at least 2 years in IMP labeling. Deep knowledge of GMP, GCP, EU CTR, Annex VI, Annex 13, FDA requirements, and experience supporting multicenter, multi-region clinical trials. Skills include proficiency in labeling systems and MS Office, strong communication, collaboration, adaptability, and a commitment to ethical practice. Preferred: experience with Veeva, process improvements, and global regulatory trends. High-Value: expertise in IMP lifecycle management, cross-functional collaboration, international regulatory compliance, and clinical trial support. Work setup: hybrid or remote; travel not specified.