Head of RA

Location Tokyo
Job type Permanent
Salary 14,000,000 - 18,000,000 JPY (Negotiable)
Reference 32666

【COMPANY OVERVIEW】

​A global healthcare company specializing in medical devices and healthcare services.

【TEH ROLE】

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.

【JOB RESPONSIBILITIES】

  • 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

【REQUIREMENTS】

  • 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