Regulatory Affairs Executive
6 months ago
**工作職責**:
1. 準備並編制註冊檔案(資料、認證申請或其他指定內容)以供上級審核和檢查。
2. 申請藥品/良好製造證書
3. 地方當局的做法/指示根據需要安排由公證人和所在國大使館對文件進行公證、合法化和認證。
4. 根據各自出口國和進口國規定的標籤要求,對提交(新產品、變體、更新)所產生的藝術品材料進行初步審查和檢查。
5. 為了跟進正在進行的任務,透過與各自專案利害關係人的有效溝通(透過團隊電話、起草信件、電子郵件)主動註冊專案。
6.根據需要申請藥品註冊延續、變更。
7. 向採購和運輸部門申請和維護藥品生產許可證和進口許可證的更新和更新證書。
8. 追蹤醫療器材GDPMD認證的有效性並根據需要更新資料庫Medcast。
9. 向上級持續追蹤、強調和更新註冊項目的任何重大(次要/重大)進展,並在月度監管報告、追蹤日誌等中總結進展。
10. 與地方當局聯絡有關監管事務。
由上級建議/指導的任何其他項目/任務。
**要求**:
擁有理學士學位
法律/監理工作職能的行政經驗。
良好的文件能力和溝通團隊精神。
**工作類型**:全職
薪水:每月 RM3,000.00 - RM4,500.00
**日程**:
星期一到星期五
**補充工資類型**:
年度獎金
**通勤能力**:
士乃 (必填)
**搬遷能力**:
士乃:開始工作前搬遷(必備)
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