CMC薬事担当者

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Job details

Company overview

We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.

Responsibilities

薬事（CMC）領域におけるグローバル申請業務及び国内申請業務を担当していただきます。

• IND/IMPD、NDA/BLA作成及び推進
• 国内申請資料作成及び推進
• その他CMC薬事にかかわる業務

Requirements

必須条件:

• 医薬品（原薬，製剤，分析）・投与デバイス・コンビネーション製品の技術開発経験またはCMC薬事業務の経験・知識（国内またはグローバル）

Salary

10 - 12 million yen

Location

Tokyo