Randstad Enterprise

Regulatory Affairs Expert

Randstad Enterprise  •  Tokyo, JP (Onsite)  •  14 days ago
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Job Description

職務内容:

以下の業務をRegulatory Expertと共に業務を行います。

・DMF新規、変更及び維持管理(原薬及び添加剤等)と製販への連絡

・外国製造業者認定の代理人としての業務

・体外診断用医薬品/医療機器 承認申請維持管理

・申請書内容と製造実態との定期的点検

・PMDA相談

・GMP適合性調査対応

・輸入確認(薬監証明)

・法改正動向確認及びグローバル薬事への展開

応募要件:

・薬剤師免許取得

・日常的な英文メールのやりとりに拒否反応が無いこと。

・他部署と積極的にコミュニケーションが取れること。

・医療業界で、薬事申請、品質保証又はCMC経験がある方は歓迎します。

Randstad Enterprise

About Randstad Enterprise

Randstad Enterprise is the leading global talent solutions provider, enabling companies to create sustainable business value and agility by keeping people at the heart of their organizations. As part of Randstad N.V. — a global talent leader with revenue of € 25.4 billion — we combine unmatched talent data and market insights with smart technologies and deep people expertise. Our integrated talent solutions – talent acquisition (RPO, MSP, services procurement/SOW and talent BPO) delivered through Randstad Sourceright, and talent development and transition (talent mobility, career coaching and outplacement) delivered through Randstad RiseSmart – help companies build a skilled and agile workforce that moves their business forward.

Industry
Consulting & Advisory
Company Size
1,001-5,000 employees
Headquarters
Amsterdam, NL
Year Founded
Unknown
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