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Regulatory Affairs Expert / Quality and Regulatory Management_Life Science at The businesses of Merck KGaA, Darmstadt, Germany

Tokyo, Tokyo, Japan -

Full Time

Start Date

Immediate

Expiry Date

24 Mar, 26

Salary

0.0

Posted On

24 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Management, Communication, GMP Compliance, DMF Management, Medical Device Approval, Pharmaceutical Regulations, Import Verification, Global Regulatory Trends, Collaboration, English Proficiency, Pharmacy License, Quality Assurance, CMC Experience, Regulatory Consultation, Manufacturing Inspection

Industry

Pharmaceutical Manufacturing

Description

ポジション： Life Science Regulatory Management : Regulatory Specialist レポートライン: Regulatory senior Manager日本人勤務先：東京勤務（週２日在宅ワーク可）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。

Responsibilities

The role involves managing DMF submissions and maintenance, acting as a representative for foreign manufacturers, and overseeing approval applications for in vitro diagnostic drugs and medical devices. Additionally, it includes regular inspections of application contents against manufacturing realities and responding to GMP compliance investigations.