Global Regulatory Affairs - CMC Talent Community

Role: Regulatory CMC specialist supporting radiopharmaceutical and biopharmaceutical product development and commercialization, with a focus on technical dossier authoring and regulatory compliance. Responsibilities: prepare and revise eCTD modules (2.3 & 3) for INDs, NDAs, BLAs, MAAs, CTAs, and post-approval submissions; ensure documentation accuracy and compliance with evolving global regulations (ICH, FDA, EMA); collaborate across Quality, Manufacturing, and preclinical teams for regulatory planning; assess manufacturing changes and develop post-approval supplements. Requirements: undergraduate degree in Biological Sciences, Engineering, or related field; experience in CMC within radiopharmaceuticals or biopharma; strong regulatory knowledge of global guidelines; excellent technical writing and communication skills; analytical and interpersonal skills for cross-functional collaboration. HighValue: expertise in CMC regulatory submissions, radiopharmaceutical development, global regulatory standards, and technical dossier preparation. WorkSetup: hybrid or remote; specific travel not specified.