開発薬事担当者/ スタッフorノンラインマネージャー

職種

• 医薬品薬事/法規対応

仕事内容

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).

求める能力・経験

Minimum Education/Degree Requirements Bachelor or Master degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Technology or Agriculture with significant practical experience related to respective TA. Further degrees, e.g. Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated.

雇用形態

給与

700万円〜1,200万円

勤務時間

休日・休暇

社会保険

備考

配属先

転勤

本社

住所

東京都品川区

制度

その他

制度備考