Regulatory Affairs Manager
2 weeks ago
**1、新產品註冊:**
- 根據相關監管要求準備和編制註冊檔案,包括:
- 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。
- 在提交之前編譯/審查/檢查檔案資料,納入相關利害關係人的回饋。
- 對藝術品進行檢查,以確保符合當地法規。
- 根據目標提交時間表向當地衛生部門提交產品註冊申請。
- 與衛生當局聯絡並回應其他請求或詢問,並跟進(必要時)直至按照目標時間表獲得批准。
- 與內部和外部利害關係人/部門聯絡,建立融洽關係並實現目標成果。
**2. 遵守監管要求:**透過及時變更和/或更新來維持現有許可證/認證/授權(例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證)的有效性,以確保供應連續性。
**3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。**
- 評估監管更新對業務的影響,並就處理事務的方法傳達見解。
- 針對出現的問題提出解決方案。
4.更新和維護監管和產品註冊資訊資料庫。
5. 妥善維護最終提交的文件和本機儲存庫。
6. 確保遵守監管事務、行政維護規定的品質程序,並規劃/建議營運改善。
7. 支持任何審計或檢查。
8. 指導/監督工作績效和直接報告的發展。
9. 透過在年度核准的預算內管理營運費用,為定期營運指標/預算計畫提供輸入。
10. 處理主管建議的任何其他分配。
**要求:**
- 擁有科學學士學位
- 監管事務方面的工作經驗。
- 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
- 熟練Microsoft Office應用程式和相關監管系統軟體。
- 在文件和溝通方面採用良好的做法。
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