药品注册（外派外资）

Job Purpose：
• Contribute in registration strategy discussion and responsible implementation of the
planned registration strategy in China independently.

• Compliance with applicable policies, procedures and other regulations.


Major Accountabilities：
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 strategy 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. Be responsible for organize China/global cross functions raise HA meeting request, prepare and attend meetings with HA and work out the meeting minutes(F2F, virtual and telephone conference);
7. Independently 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, DSUR, PSUR, RMP, Safety Communication letter to HA CMC, annunal reports and timely update in Novartis regulatory systems;
9. Monitor regulatory practice changes and report to line manager timely;
10. Assist line manager to coach and provide technical and regulatory advice to junior levels if necessary;
11. Ensure regulatory activities comply with Novartis internal SOPs for routine work;
12. To be assigned as coach to the junior staff or new comer as needed.