求人番号：68796
外資系製薬メーカー
レギュラトリーアフェアーズ（薬事）【シニアアソシエイト】：外資系製薬会社！
- 業種
- 製薬メーカー
- 職種
- 薬事
- 年収
- 600万円～950万円
- 勤務地
- 東京都
外資系企業
海外折衝
英語力が必要
土日祝休み
リモートワーク可
- 仕事内容：
- TA: Immunology
The Regulatory Affairs TA will be responsible for ensuring first time approval of new products and
new indications for existing products through participation in local brand teams as well as educating
to his or her staffs.
・Develop local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelines
・Ensure Japan submission requirements are communicated to relevant regional and global regulatory team
・Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant
・Inform group manager of Regulatory Affairs and New Product Information (NPI) team of progress of
applications and issues impacting local applications
・Assist with major submissions to register NCEs or new indications for existing products when needed
・Educate and train regulatory strategy to the staffs
※詳細はお問合せください。