募集要項
- 仕事内容
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Job Summary：
・To manage Japan RA-CMC group
・To facilitate cross functional (with JAPAC RA-CMC, Japan RA, Japan QA etc．) matters
Key Activities
・Prepare CMC components in NDA dossiers for Amgen products in collaboration with the Senior Manager, Regional and Global Reg CMC
・Prepare and update CMC document for CTN in collaboration with Regional and Global Reg CMC
・Participate in Project Teams as an Local CMC expert
・Interact with Japanese Health Authorities
・Provide CMC information for investigational products used in clinical trials in Japan
・Prepare documents for GMP inspection in collaboration with local QA
- 応募資格
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- 必須
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Knowledge and Skills：
・CMC-specific local regulatory knowledge & experience
・Biologics-specific regulatory knowledge & experiences – preferred
・Communication skills in Japanese and English
・Team player
・English conversation, read, and writing
・Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project
Education & Experience：
・Over total 10 years’ experience for regulatory CMC and/or CMC (Operation) of pharmaceutical industry including biologics for supporting PMDA consultation, CTN and NDA submission in Japan
- 歓迎
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Education & Experience (Preferred)：
・Master or Doctor degree
- 募集年齢(年齢制限理由)
- 35歳～55歳 （特定年齢層の特定職種の労働者が相当程度少ないため）
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 1300万円 ～ 1500万円（経験・能力により決定）
