Job title: CMC Regulatory Manager Location: Hatsudai, Tokyo About the job Role & Responsibilities The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC &
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Title: Senior Quality Specialist Location: Japan HQ - About the job As Senior Quality Specialist (Expert Japan) within our Vaccine R&D Quality Operations team, youll lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance
職務内容: 以下の業務をRegulatory Expertと共に業務を行います。 ・DMF新規、変更及び維持管理(原薬及び添加剤等)と製販への連絡 ・外国製造業者認定の代理人としての業務 ・体外診断用医薬品/医療機器 承認申請維持管理 ・申請書内容と製造実態との定期的点検 ・PMDA相談 ・GMP適合性調査対応 ・輸入確認(薬監証明) ・法改正動向確認及びグローバル薬事への展開 応募要件: ・薬剤師免許取得 ・日常的な英文メールのやりとりに拒否反応が無いこと。 ・他部署と積極的にコミュニケーションが取れること。 ・医療業界で、薬事申請、品質保証又はCMC経験がある方は歓迎します。...