Manager, Regulatory LCM CMC

A Manager in Global Regulatory Affairs overseeing the life-cycle management of CMC filings, variations, and supplements for US, EU, and Japan markets. The role involves evaluating regulatory impacts of manufacturing changes, updating regulatory dossiers, and collaborating with cross-functional teams to ensure compliance with FDA, EMA, and other global health authority requirements. This position requires deep expertise in biologics manufacturing processes and ICH guidelines to support product lifecycle activities and regulatory inspections.