- グローバルとの連携を通じて薬事・品質保証・安全管理の幅広い経験を積める環境
- 裁量の大きいポジションで、経営層への提言や戦略的業務に関与
企業情報
世界的に展開するヘルスケア関連企業で、患者の安全と高品質な製品提供を使命としています。革新的な医療ソリューションを支える重要な役割を担うことができます。
職務内容
- 医薬品・医療機器の薬事申請
- MF登録および関連書類の管理
- GQP/GMP適合性調査対応
- 製造販売後安全管理業務の統括
- 苦情対応責任者としての業務遂行(医薬品・医療機器)
- グローバルRAや製造拠点との情報収集・調整
理想の人材
- 薬品・医療機器に関する薬事業務経験
- GQP/GMP、製造販売後安全管理に関する知識
- 日本の薬事規制・関連法令の理解
What's On Offer
- フレックスタイム制度・リモートワークあり
- グローバルプロジェクトへの参画機会
- キャリア開発・研修制度充実
- 社会保険完備・各種手当あり
Contact: Kao Toyama
Quote job ref: JN
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