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Regulatory Affairs Executive

2 weeks ago

Sungai Buloh, Malaysia Yanling Natural Hygiene Sdn Bhd Full time

**職責**:
1. 辦理產品註冊(傳統藥物/天然產品、保健品和OTC)。

2.與監理機關的聯絡和談判

3. 向客戶/同事提供有關法規的建議

4. 協調與規範性文件或提交資料的準備相關的工作。

5. 隨時了解監管立法和指南的變化。

6. 維護現有和新興法規、標準或指導文件的最新知識庫。

7. 根據監管機構的要求,準備或直接準備額外資訊或答复,例如上市後監督。

8. 依照監管機構的要求指導實驗室樣本的採集和製備

9. 根據需要準備或維護技術文件以獲得和維持產品批准。

10. 準備對客戶資訊請求的答复,例如產品資料或書面監管事務聲明。

11.建議更改公司程序以因應法規或變化的變化

12. 根據需要協調召回或市場撤回活動。

13. 需要研究支持產品聲明的科學或臨床論文。

14. 能夠密切注意細節,對科學問題有良好的閱讀理解能力。