医療開発本部レギュラトリーアフェアーズジャパン CMC薬事（スタッフ～ノンラインマネージャー）

職種

• 医薬品CMC薬事

仕事内容

Basic purpose of the job The manager of RRL JP CMC has responsibility to develop and implement regulatory strategy for the assigned products/projects as LRL, and exercises activities which include: 1) An integral member of the Regulatory Excellence Team, contact point of GRLs for CMC related matters, and contributes to the delivery of robust regulatory strategies and coordination of local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals. 2) 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 CMC related matters (including Master File).

求める能力・経験

Experience: • More than 3 years’ experience in RA including new drug registration. • More than 3 years’ experience in R&D and/or Medical development. • Practical experience in handling new developments, registrations and maintenance of Marketing authorizations. • Experience with direct Health Authority interactions. • Preferably international work experience. Language skills: • Japanese: Fluent • English: Excellent in communicating in English

雇用形態

給与

700万円〜1,300万円

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