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【太陽ファルマ社配属】薬事/Regulatory Affairs（CMC薬事、薬制薬事）
| Hiring Company | 太陽ホールディングス株式会社 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 6 million yen ~ 10 million yen |
Job Description
【求人No NJB2027530】
日本における承認申請業務、当局通知及び製薬業界情報のキャッチ、添付文書及び添付文書関連資材の改訂等
・市販製品の薬事申請・提出（一変・軽微変更等）用書類作成、製造所や製造方法の変更など
・当局対応
・承継元企業からの各製品承認書引き継ぎ対応
・承継品目に関する承認書記載内容の最新情報把握
※日本ユニシス製のOpenTrustyRを導入しております。
※自社での製剤研究や海外事業拡大も視野にあり、自社での新規薬事申請も想定しております。
General Requirements
| 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 |
Required Skills
【必要な能力・経験】 ・医薬品に関する法令、ガイドライン等に関する知識 ・医療用医薬品製品情報資材作成等に関する知識 ・製薬会社での薬事関連業務経験Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 6 million yen ~ 10 million yen |
| Work Hours | 09:00 ～ 17:30 |
| Holidays | 【有給休暇】初年度 10日 6か月目から 【休日】週休二日制 土 日 祝日 夏季休暇 年末年始 【有給休暇】初年度10日、最高… |
| Industry | Chemical, Raw Materials |
Job Category
- Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
