The Regulatory Affairs Senior Manager is responsible for leading regulatory activities from development through life cycle management in collaboration with global and Japan stakeholders. Key responsibilities include managing interactions with health authorities, leading NDA and sNDA submissions, preparing Japan-specific regulatory documents, overseeing post-marketing change control processes, and managing electronic package inserts and promotional material reviews. The role also involves mentoring team members, managing vendors, supporting SOP updates, and ensuring compliance with regulations while driving process improvements.