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【800～1200万円】【関西窓口】【東京・大阪】薬事スペシャリスト（Regulatory Affairs Specialis…
| Hiring Company | 株式会社新日本科学ＰＰＤ |
| Location | Osaka Prefecture |
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 12 million yen |
Job Description
【求人No NJB2339879】
・規制当局（PMDA、MHLW等）との各種相談業務
・承認申請関連業務（クライアント様への申請業務サポート）
・薬事情報の収集、維持・管理に関する業務
・その他（各種会議・研修等への参加）
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
【必須（MUST）】
再生医療等製品のRS戦略相談の対応経験（特に品質相談）
新薬・再生医療等製品の承認申請に関する薬事経験（特にCMC・品質関連）
→遺伝子治療のCMCのご経験がある方
理系の大卒以上
英語力（直近のTOEICスコア750以上、又は同等以上の英語力）
クライアントとの会議が週1回程あるためスピーキング力も必須となります。
Job Location
- Osaka Prefecture
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 12 million yen |
| Work Hours | 09:00 ～ 18:00 |
| Holidays | 【有給休暇】試用期間終了後に10日～最大20日間付与 【休日】完全週休二日制 土 日 祝日 GW 夏季休暇 年末年始 休暇：夏… |
| Industry | Contract Research Organization |
Job Category
Company Details
| Company Type | International Company |
