臨床研究專員(CRA)

1.藥品安全性監視計畫之執行及嚴重不良反應通報。 

Execution of drug safety surveillance program and reporting of serious adverse events. 

2.藥品/醫材上市後變更及展延送件  

Submission of renewal and variations for drugs and medical devices 

3.跨部門溝通  

Work closely with project teams.  

4.送件資料歸檔及維護 

Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted. 

5.其他主管上級交辦事項 

Complete assigned tasks

1. Evaluation of submission feasibility for in-licensed products (major) and domestically manufactured products in the APAC region (KR, TW, HK, SG, MY, TH, VN, PH, and ID) 

2. Coordination of the due diligence and production of the gap list 

3. Evaluation and plan of the design, the budget, and the timeline for the bioequivalence study, the bridging study, and the clinical study in KR and TW 

4. Communication with the APAC regulatory teams and partner companies to resolve the submission gap in the target markets 

5. Design and consolidation of the regulatory strategy of the key milestone, the submission pathway, the submission timeline, and the launch timeline in the target markets 

6. To review the License and Service Agreement 

7. To support new submissions in Taiwan 

8. To update of the APAC regulations 

9. To prepare the consultation materials 

10.To provide the justification materials on the non-clinical and clinical studies for the deficiency letter 

11. To compile the ACTD format from the CTD format 

12. To monitor submission progress on all company‘s projects 

13. To provide improvement plans 

14. The other tasks 

1. 協調法規相關部門與供應商評價授權產品 

2. 評估產品於亞太地區註冊之可行性，準備註冊所需相關技術文件與試驗 

3. 在產品開發及送件準備期間提供法規要求的指引，協助其符合國際法規 

4. 即時提供註冊用產品主檔案 

5. 協助提供法規更新計畫 

6. 即時支援產品維護用技術文件 

7. 協助擬定合理且經濟可行之註冊計畫 

8. 協助執行註冊計畫