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Hiring Company | 非公開 |
Location | Osaka Prefecture |
Job Type | Permanent Full-time |
Salary | 4.5 million yen ~ 7 million yen |
【求人No NJB2046174】
【業務内容】医薬品製造販売承認後の薬事全般業務
(1) 医薬品・医療機器等法及びその関連法令遵守に関する業務
・医薬品医療機器等法等遵守の状況の確認
・医薬品医療機器等法等に関するサポートや教育
・薬事関連行政通知等の社内向け情報発信
(2) 業許可等管理
・自社の許可等(製造販売業、製造業、卸売販売業、向精神薬製造製剤免許)の管理
・承認に係わる製造業許可及び認定の管理
(3) 定期GMP適合性調査関係業務
・申請及びそのスケジュール管理
(4) 承認関係業務
・承認情報管理システムの管理
・承認申請業務及び当局対応(開発部申請案件を除く)
・承認取得後の薬事資料の管理
・一変申請中品目の薬事資料の管理(薬制室担当分)
(5) 医薬品等総括製造販売責任者補佐業務
Minimum Experience Level | No experience |
Career Level | Mid Career |
Minimum English Level | Daily Conversation |
Minimum Japanese Level | Native |
Minimum Education Level | Bachelor's Degree |
Visa Status | Permission to work in Japan required |
Job Type | Permanent Full-time |
Salary | 4.5 million yen ~ 7 million yen |
Work Hours | 08:40 ~ 17:20 |
Holidays | 【有給休暇】初回の年次有給休暇は,入社から3ヶ月経過後に以下の日数を付与しその後は規程による。 ※1/1~6/30入社の場合:… |
Industry | Pharmaceutical |