BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Tokyo, Japan
Job Description Summary
Are you looking for a new challenge that will include being part of a new unit within the Regulatory Affairs team? The RA department is looking for someone who will be able to a future leader in our New Drug Approval section. This is a new position with the person coming in will be able to pioneer member that will require their expertise in drug registration and price reimbursement. The role has a promising career path and within a few years and right candidate, we hope they will be able to step up and be a manager.
Manage product registration for Drug (NDA)
Create and apply Drug price reimbursement document.
Review and approval product labeling and other related material to ensure consistency with labeling included in registration documents.
Help establish SOPs and work instructions under Drug regulation.
Help conduct for training on SOPs, Work Instructions, PMDAct, and other applicable laws and regulations
Internal consultation based on PMDAct including regulatory determination and support the team of the expertise area
Business Units: closely aligned with business unit(s), understand business priorities, keep business informed of RA progress, resolve issues
BDX Regulatory: obtain product information required for product registration in Japan
LM: Request to obtain FMR/FMA and QMS/GMP inspection submission in align with product registration.
QM: provide required regulatory actions for product changes
PMDA: submit Shonin to PMDA, and manage inquiries from PMDA
External Trade Association: be sensing, monitoring, and influencing as a part of industrial association.
Primary Work Location
JPN Tokyo - Minato-ku
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.