RAマネージャー/シニアマネージャー

Job Details

Job Summary

This position works directly under the Director of Regulatory Affairs, and would involve working with global RA teams and communicating with the PMDA. This company is actively looking to expand their pipeline and as a result are in need of skilled regulatory professionals.

 

Responsibilities

・治験計画届出業務(届出作成、提出、PMDA対応、Global RAとの調整)
・対面助関連業務
・製造販売承認申請関連業務
・市販製品の変更管理業務
・薬事オペレーション業務

 

Qualifications

・開発薬事業務/市販後薬事業務/薬事オペレーション業務のうち、いずれかのご経験をお持ちの方

Job application