CMCRA specialist

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MAIN FOCUS AND MISSION:

・Responsible for the activity of Chemistry, Manufacturing & Control for development and marketed products.

・With the Global RA CMC for development projects, ensure the CMC quality of the files in Japan.

・Liaises with the Global Manufacturing Team for marketed products ensuring that the appropriate Partial Change Applications (PCA) and Minor Change Notifications (MNC) are made on time in line with the global manufacturing change processes (for marketed products).

ROLE & RESPONSIBILITIES:

・Development of CMC Regulatory Strategy:

Collaborate with global CMC and related departments for pharmaceutical development projects to discuss and establish a CMC regulatory strategy aimed at fulfilling domestic CMC approval requirements and achieving rapid approval in Japan.

CMC薬事戦略の策定：医薬品開発品目についてグローバルCMC等関連部署と連携し、本邦におけるCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略を協議・構築する。