薬事部門 開発薬事部(オンコロジー)グループマネージャー

    • Tokyo, Japan

Site Name: Japan - Tokyo - Akasaka
Posted Date: Apr 23 2020


  • Job Purpose & Key Responsibilities

  • Develop and implement Japan regulatory strategy for the oncology projects in Japan, aligned with global regulatory strategy.
  • Lead oncology group and be role model for the staffs.
  • Serve as the primary interface to global regulatory affairs.
  • Take responsibility as the primary interface for health authority (PMDA/MHLW) activities such as consultation meeting, other negotiation based on regulatory science.
  • Take responsibility for leading the preparation of submissions, which include CTNs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
  • Represent Regulatory Affairs in various cross-functional teams, including Project Teams, JNDA Submission Teams, etc.
  • Encourage to secure/update knowledge regarding innovative development in oncology based on regulatory science, considering regional competitive landscape, regulatory environment
  • Report to head of New Drug RA Dept, Regulatory Affairs


Required Skill, Experience, Etc

Basic Qualification

Skill

  • Thorough knowledge of global regulatory guidance related to the overall global regulatory strategy.
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be able to be innovative in way of thinking, analyzing and solving problems with minimal supervision and attention to detail.
  • Ability to attract talent, challenge and manage and develop direct reports

Experience

  • Experience for more than 10 years in drug development, including experience for more than 5 years in regulatory area to work in global circumstance.
  • Experience in oncology drug's regulatory submissions and approvals.
  • Thorough knowledge of the drug development process in Japan, CTN, PMDA consultation and NDA.

Education/certification/Language
  • Bachelor's degree in scientific discipline
  • Excellent communication skill in English to be able to make a deep discussion in regulatory strategy with global relevant members.

Preferred Qualification

experience

  • Experience in multiple phases of oncology development
  • Manage performance for direct reports
  • Assist in managing the Workforce plan and resource demands (including above project work and staff recruitment)

Education/certification/Language
  • Master's degree or higher in scientific discipline, advanced scientific degree


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