管理担当

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Job details

Company overview

Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

Responsibilities

市販後CMC変更管理に対する、①製造所等から提案される変更案件のリスト化、および薬事評価要否検討②上記の薬事評価要否検討結果に対する関係部所との協議、合意形成③各変更が最終的に紐づく製剤ロット、および市場出荷時期の可視化④各変更の承認希望時期の設定、および関係部所への情報提供⑤変更案件の薬事対応ステータス、および影響を受ける製剤ロットの確認

Requirements

必須条件:

• 製薬企業でのQA、RA、CMO管理等の業務において、市販後CMC変更管理に関わる業務経験

Salary

11 - 15 million yen

Location

Tokyo