Manager, Regulatory Affairs (CMC)

Role: Manager, Regulatory Affairs (CMC) at Telix Pharmaceuticals, responsible for authoring and managing CMC regulatory dossiers for radiopharmaceutical and biopharmaceutical products across development stages. Responsibilities include preparing Module 3 technical documentation for submissions such as INDs, NDAs, BLAs, and post-approval variations; ensuring compliance with evolving global regulatory guidelines (ICH, FDA, EMA); collaborating with Quality, Manufacturing, and preclinical teams; and providing regulatory assessments for manufacturing changes and risk mitigation. Requirements: undergraduate degree (advanced degree preferred), 7+ years in CMC regulatory roles within radiopharma or biopharma, strong knowledge of global CMC regulations, excellent technical writing and communication skills, and ability to work cross-functionally. High-value specifics: focus on radiopharmaceuticals, late-stage clinical products, global regulatory submission experience, and technical dossier development. Work setup: hybrid or remote options, with international collaboration.