RA Manager - Abbott Molecular

The Regulatory Affairs Manager oversees the pharmaceutical affairs strategy for in vitro diagnostic (IVD) and related medical devices in Japan, driving product lifecycle management from development to market access. This role leads regulatory submissions, reimbursement strategies, and negotiations with the PMDA and Ministry of Health, Labour and Welfare to maximize product value and patient access. The position also involves managing the regulatory team, ensuring quality management system compliance, and collaborating with global and cross-functional teams to support business growth.