Commercial Regulatory Assurance Manager
- 〜 1300万円
- Manager of Commercial RA will lead the Regulatory Affairs function in Japan commercial operations. The role has direct management responsibility for 5 staff.
・To manage the role of Regulatory Affairs function.
・To manage projects relevant to Regulatory Affairs (Registration, Regulatory strategy, etc.) on time in budget.
・To lead IVD and Medical Device registration and discuss with Japanese regulatory agencies.
・To lead clinical trials for IVD registration and discuss with clinical site or commercial laboratory.
・To lead new reimbursement request for IVD Class III (New) registered product and discuss with Japanese MHLW to get the reimbursement.
・To discuss and collaborate with counterpart in overseas headquarter/production and development site.
・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.
DESIRABLE KNOWLEDGE AND EXPERIENCE：
・Experiences of IVD reimbursement application (E3) and discussion with MHLW
・Experience and/or knowledge of Molecular Biology
・Knowledge of Molecular Biology, Immunochemistry and clinical chemistry