Act as the General Marketing Supervisor (GMS), overseeing Quality Assurance and Pharmacovigilance functions and reporting to the legal representative. Manage both pre\- and post\-approval GMS responsibilities with effectiveness and accountability.
Develop and implement regulatory strategies for assigned pharmaceutical products, executing activities independently in compliance with Japanese regulations, guidance, and established procedures.
Lead the preparation and submission of regulatory documentation, including Module 1 and Application Forms for Marketing (AFM), provide regulatory intelligence, liaise with local health authorities (PMDA and MHLW), support NHI price listing, and define overall regulatory strategies.
Serve as GMS for assigned products, with full accountability for achieving regulatory milestones across the entire product lifecycle and for all categories of medicinal products.
Apply in\-depth regulatory expertise to support approvals and ensure uninterrupted product supply, proactively identifying regulatory risks and developing appropriate mitigation strategies.
