募集要項
- 募集背景
- 増員
- 仕事内容
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【パソナキャリア経由での入社実績あり】※ノンラインマネージャーでの採用となります。
【職務概要】※詳しくはキャリアアドバイザーまでお問い合わせください。
The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include:
An integral member of the Regulatory Excellence Team, a contact point of Global Regulatory Lead (GRL), responsible for a particular therapeutic area(s), contributes to the delivery of robust regulatory strategies, leads task team for J-CTD, and coordinates local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.
Interface & contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA consultation as well as marketed products, Global RA and other cross functional stakeholders for product and project related regulatory activities for the assigned therapeutic area(s).
Re…
- 応募資格
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- 必須
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■新薬登録を含む開発薬事での5年以上の経験。
■新たな開発、登録および販売認可の維持を扱う実務経験。
■当局との直接のやり取りの経験。
■英語力:ビジネス会話(目安TOEIC730)
- 歓迎
- 応募資格をご覧下さい
- フィットする人物像
- 応募資格をご覧下さい
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 勤務時間
- 08:45~17:20
- 年収・給与
- 700万円~1400万円
- 休日休暇
- 完全週休二日(土日) 祝日、年末年始、創立記念日、セレクト休日、有給、慶弔、リフレッシュ休暇