Regulatory Scientist

8時間前

Location: Tokyo, Tokyo JP Randstad Sourceright

Job Number:

External Description:

■業務内容
- 市販後製品のメンテナンス

薬事戦略の策定、提出書類の作成、他部署との連携や調整及び当局対応を通じて、市販後製品の安定供給に貢献する

 ・承認事項一部変更承認申請

 ・軽微変更届

 ・GMP適合性調査申請(一変、定期)

 ・市販後製品の包装資材検証

 ・情報公開請求対応

 ・製品の承継

・製品の承認整理

 ・承認書及び承認関連資料の管理

-   業態の更新、変更を適切なタイミングで行い、当局との折衝を行う

 ・医薬品製造販売業

 ・医療機器製造販売業(高度管理医療機器)

- Global regulatoryとの協働(日本周辺各国との連携を含む)

- 要請国への製剤証明(CPP)の提供

・関連文書の作成、提出、当局との交渉、公証に貢献し、要請国にCPPを提供する

-    市販品の危機管理

 ・薬事戦略の策定や当局との協議を通じて、製品あるいは会社に対する諸問題の解決に貢献する

Job Number:

Community / Marketing Title:
Regulatory Scientist (post-marketing)

Location_formattedLocationLong:
Tokyo, Tokyo JP

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