お仕事情報

お仕事情報

RA CMC Manager:SS-3543MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-3543MY
募集職種 RA CMC Manager
職務内容 Summary
•Regulatory CMC Japan Manager is responsible for execution of the Japan-specific product strategies align with the global strategy.
•This position prepares and submits NDA/CTD dossiers in collaboration with Global Reg CMC and Operations, and may need support from the local Senior Manager partially.
•This position provides CMC information of investigational products used in clinical trials to local Dev Ops and external vendors.
•This position also closely communicates with Regional Reg CMC for registration and maintenance of Foreign Manufacturer Accreditation (FMA).

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 and PST as an Local CMC expert
•Interact with Japanese Health Authorities
•Provide CMC information for investigational products and medical devices used in clinical trials in Japan
•Execute FMA renewal, registration, and the Change Notification
応募要件 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 (Basic)
•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

Education & Experience (Preferred)
•Master or Doctor degree
勤務地 東京
年収 1000万円~1500万円
最終学歴 理系大卒
推奨される資格要件 PhD、理系
その他

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