Location: Tokyo, Tokyo JP Randstad Sourceright

Job Number:

External Description:

募集職種について


このポジションでは、日本におけるCMC関連の規制業務を担当し、申請書類の作成や承認取得、製品の輸入・製造・販売に関する課題解決を支援します。

一緒に働くチームについて


あなたは、規制業務を専門とするチームの一員として、国内外の関係者と連携しながら高品質な申請書類の作成と承認取得を目指します。

主な業務内容


· 日本におけるCMC規制戦略の実行
· 新薬承認申請書類の作成と提出
· GMP事前査察の申請業務
· 輸入・製造・販売に関する課題の分析と解決支援
· 規制文書の品質管理
· 製造販売承認の維持と更新

応募資格・スキル


· 理系学士または修士号を保有していること
· 規制業務または品質管理の経験が5年以上あること
· 国際的な業務経験がある方歓迎
· 規制当局との関係構築経験
· 英語でのコミュニケーション能力
· 科学的知識と文書レビュー能力

Job Number:

Community / Marketing Title:
Regulatory CMC Scientist

Location_formattedLocationLong:
Tokyo, Tokyo JP



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