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1. Be fully responsible for the registration dossier preparation and submission of assigned projects; Be responsible for timely order the registration sample, dossier, certificates;
2. Contribute to the discussion of registration plan with both local and global team;
3. Achieve the target timeline of submission and approval;
4. Track the registration status in CDE and NMPA and timely report to the line manager;
5. Organize to answer technical questions referred by HAs;
6. Coordinate of F2F discussion meeting with HAs;
7. Communicate with HQ about the issues related to the responsible product registration; for example dealing with relative issues on drug quality test in HA's lab;
8. Accountable for ensuring regulatory compliance for the responsible brands like CMC, CDS, PSUR, RMP, registration master file and timely update CPDS, systems like Insight, iMedidata and etc. ;
9. Responsible for artwork preparation and communicate with site or via Catalyst in time.
10. Monitor regulatory changes and report to line manager timely
11. Ensure regulatory activities comply with internal SOP for routine work