RAスペシャリスト

Job Details

<職務内容>

・薬事戦略策定
製造元R&D等への説明と同意、PMDA相談、ステークホルダーへの説明と同意
・薬事申請・承認取得
申請データ収集・評価、信頼性調査対応、QMS調査対応(サポート)、申請資料作成、行政の説明・プレゼン、照会回答
・保険戦略策定
経済課相談、学会との相談、ステークホルダーへの説明と同意
・保険適用希望書作成

<応募要件>

・学部卒以上、理系歓迎
・2年以上のクラス3~4の薬事申請経験(循環器歓迎)
・PMDA折衝経験歓迎

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company