Danaher Corporation Regulatory Affairs Manager Beckman Coulter DX Tokyo in Koto-Ku, Japan
I. JOB SUMMARY
Manager of Commercial RA will lead the Regulatory Affairs function in Japan commercial operations. The role has direct management responsibility for 4 staff at Ariake Office.
II. Specific responsibilities
1) To manage the role of Regulatory Affairs function.
2) To manage projects relevant to Regulatory Affairs (Registration, Regulatory strategy, etc.) on time in budget.
3) To lead IVD and Medical Device registration and discuss with Japanese regulatory agencies.
4) To lead clinical trials for IVD registration and discuss with clinical site or commercial laboratory.
5) To lead new reimbursement request for IVD Class III (New) registered product and discuss with Japanese MHLW to get the reimbursement.
6) To discuss and collaborate with counterpart in overseas headquarter/production and development site.
7) To strengthen the RA organization and develop members’ talents.
• More than bachelor's degree in Pharmaceutical Sciences or equivalent
• Experiences of management of function
• Experiences and knowledge of IVD and MD industries
• Experiences of IVD and MD registration
• Experiences of IVD or MD clinical trial for registration
• Deep knowledge of PMDA Act (including related ministerial ordinances
• Experience of discussion/negotiation with regulatory agencies
•Business level English (Frequent communication in English by e-mail, teleconference, etc.)
• Communication skills to discuss with medical doctor, professor and PMDA or MHLW officer.
• Leadership ability
DESIRABLE KNOWLEDGE AND EXPERIENCE
• Experiences of IVD reimbursement application (E3) and discussion with MHLW
• Experience and/or knowledge of Molecular Biology
• Pharmacist License
• Knowledge of Molecular Biology, Immunochemistry and clinical chemistry
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.