Tokyo Michael Page
ハイブリッド勤務で在宅とオフィスの柔軟な働き方が実現可能
グローバルCMCチームとの連携で戦略的なキャリアを築ける

企業情報

革新的な医薬品の研究開発に注力し、グローバルに展開するヘルスケア企業。患者さんの生活の質向上を目指し、科学と情熱を融合させた製品開発を行っています。

職務内容

日本におけるCMCレギュラトリー戦略の立案と実行
グローバルCMCチームとの戦略整合性の確保
J-NDA申請に向けたCMCモジュール(QOS, MAAF, M3)の最終化
PCA(一部変更申請)およびMCN(軽微変更届)の作成・提出
規制当局とのコミュニケーションおよびブリーフィング資料の作成
製薬開発・技術部門との連携による申請資料の作成・レビュー

理想の人材

製薬・ヘルスケア業界での経験10年以上
日本におけるCMCレギュラトリー業務経験(3〜6年程度)

What's On Offer

ハイブリッド勤務制度(在宅+オフィス)
グローバルチームとの協働による成長機会
社内外のステークホルダーとの連携による幅広い経験
継続的な改善活動への参画機会
社会的意義の高いプロジェクトへの関与

Contact: Kao Toyama

Quote job ref: JN
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