The role is responsible for overseeing global regulatory affairs, quality systems, and compliance across all manufacturing sites, ensuring alignment with international standards including FDA, EMA, PMDA, and Health Canada. This includes managing a portfolio of over 50 active regulatory dossiers (DMFs, CEPs, J- DMFs, etc.), leading end-to-end dossier lifecycle activities from development through post-approval change management, and acting as the primary interface with regulatory agencies and customers.