A global healthcare company specializing in medical devices and healthcare services.
You will be responsible for leading both the regulatory and clinical teams in Japan, while working closely with global to ensure Japan is a pillar of global success.
Managing relationships with government agencies, regulatory agencies including PMDA
Create, implement and manage strategy for all thing’s regulatory
Lead and align clinical strategies in Japan
Represent Japan clinical and regulatory in global strategy decisions
Develop a team capable of delivering positive results on a consistent basis
Manage external partners including CRO`s and other vendors
5+ years in regulatory approvals
Demonstrated leadership responsibilities and experience
Understanding of both pharmaceutical and medical device regulations for approvals, QMS and insurance policies
Language skills – Native Japanese and Business Level English required