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Manager or Staff of Regulatory Science Expert Group

年収:800万 ~ 1200万

ヘッドハンター案件

部署・役職名 Manager or Staff of Regulatory Science Expert Group
職種
業種
勤務地
仕事内容 Basic Purpose of the job
1 This position is responsible, as a CMC Regulatory Science Expert, for writing and reviewing CMC relevant documents as well as assessing risks on clinical trials and future submission in Japan for all BI projects (New Molecular Entity) in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) as well as in collaboration and coordination with BI partners.

Accountabilities
1 Author and review the CMC relevant documents for regulatory submission (e.g. CTD, IB, etc) in Japan in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.)

2 Contribute the project team from the CMC aspects in preparing any clinical study plans and regulatory relevant documents in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) in view of future submission in Japan

3 Interface to regulatory agencies (e.g., PMDA) based on the global strategy
応募資格

【必須(MUST)】

Required Education
Bachelors Degree 学部卒
薬学,生物学,その他医薬品のCMC開発に関連する分野

Required Capabilities (Skills, Experiences, Competencies)
-Exceptional knowledge of the drug development for CMC part (特にバイオ医薬品や再生医療等製品における経験)
-Developing submission strategy in Japan in accordance with Japanese drug regulations based upon scientific rationale

Language Skills & Proficiency
Japanese Native Level/Fluent
English Business level

Comments:
Excellent oral and written presentation skills in English required

Special Work Experience
-10 years of experience in an international or local pharmaceutical R&D organization
-Strong CMC background with proven performance record (not less than 3 multiple complex projects)
-International work experience (cross-cultural competence)

更新日 2021/10/15
求人番号 1915321

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