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。
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