社名
社名非公開
職種
薬事、メディカルライティング
業務内容
化粧品製造販売業者 ブランド薬事業務の遂行【主要業務】1. (70%) ブランド薬事規制業務• マーケティングおよび R&D と協力し、製品の成分、製品訴求、および製品表示が日本の規制に適合している事の確認• 医薬部外品の申請書類作成・申請業務医薬部外品の外部機関への承認申請のための試験(試験方法の検討・相談から申請データの作成まで)、必要に応じて医薬部外品原料規格に基づく試験依頼外国製造業者の登録• 化粧品の届出業務2. (30%) 安全管理責任者(安責)業務• GVP の順守・運用・維持• 有害事象(皮膚クレーム等)の対応
求められる経験
・薬学・化学の学位
...
senior regulatory affairs specialist (薬事）.
- posted 18 january 2024
- closes 30 january 2025
experience
・薬学・化学の学位 ・化粧品・医薬部外品の申請業務経験 ・輸入化粧品会社での医薬部外品申請業務経験 ・外資系化粧品会社での経験。 ・ビジネスレベルの日本語と英語でのコミュニケーション
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