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外資系、グローバルの転職・求人情報なら[Bilingual Recruitment Solutions]

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Country Sourcing Manager

Top Global Pharmaceutical Company

職種プライシング(価格設定)
給与 1400 - 1800 万円
日付2016-05-19
業種製薬
勤務地東京
求人番号Job-00007353

会社概要:

It is the world’s largest independent biotechnology company. This company believes innovation in business, collaboration, resource-sharing and patient access is as critical to serving people’s health as what occurs in a laboratory.

業務内容:

Key Activities:
  • Develop local strategy and execute coast reduction action plans
  • Communicate with Japanese health care authorities and provide necessary documrents
  • Interact with Japanese Health Authorities
  • Manage investigational products and lab kits in clinical trials in Japan
  • Organize and conduct FMA registration and the Change Notification

応募条件:

Knowledge and Skills:

  • CMC-specific regulatory knowledge & experience
  • Biologics-specific regulatory knowledge & experiences – preferred
  • Devices-specific regulatory knowledge & experiences – preferred
  • Communication skills
  • English conversation, read, and writing
  • Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project
Education & Experience (Basic): 
  • Over total 10 years experience for regulatory CMC and CMC of pharmaceuticals including biologics for supporting PMDA consultation, CTN and NDA submission in Japan
  • Education & Experience (Preferred):Career Path Scientific/Technical


BRS Consultant

Satoshi Nakano

IT Application

Tel: 03-6370-7398

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