- 〜 700万円
- ・To lead projects relevant to Regulatory Affairs (Registration, Regulatory strategy, etc.) on time.
・To lead In Vitro Diagnostics (IVD) and Medical Device (MD) registration and discuss with Japanese regulatory agencies.
・To lead clinical trial for IVD registration and discuss with clinical site or commercial laboratory.
・To lead documentation and administration for documents relevant to Regulator Affairs (e.g. IFU/package insert/product label, regulatory description for products, Product Master Formula).
・To lead administration of manufacturing sites relevant to IVD/MD marketing approval.
・To lead QMS registration and administration for MD/IVD marketing approval.
・To lead regulatory compliance for business issues arising from business function. (e.g. advertisement and promotion for products).
・To discuss and collaborate with counterpart in overseas headquarter/production and development site.
・To support Commercial Regulatory Manager.
- ・Education: Bachelor's degree in Science or equivalent; pharmaceutics is preferable.
・Language: Native Level Japanese and Intermediate level English (Frequent communication in English by e-mail, teleconference, etc.)
・Experiences and knowledge of IVD/MD industries
・Experiences of IVD/MD registration
・Deep knowledge of PMDA Act (including related ministerial ordinances
・Cooperative and team-work skill