[MedTech] 薬事本部 BURA Surgery Advanced Surgery 薬事スタッフ

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

目的:薬事申請を行うためのポジション(Surgery領域担当を検討中。ただし、経験や希望に応じて調整可)

役割:担当製品群の薬事申請及び承認等取得、変更管理等の薬事対応業務全般の遂行

主な義務と責任


* 担当製品の薬事戦略立案から、薬事申請(承認申請、認証申請、届出)•承認等取得


* 変更管理に至る薬事対応業務全般(行政相談を含む)の推進及び実施


* 社内規定に基づ