职责描述:
1. Establish, maintain and develop good relationships with the State Drug Administration (SDA), to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).
2. Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and *** requirements.
3. Ensure that ***Bio. Regulatory Affairs are kept fully informed on the current regulatory status of all assigned products.
4. Ensure that Import product labeling and PI is consistent with SDA guidelines and requirements.
5. Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to SFDA.
6. Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with SFDA and ***requirements.
7. Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.
8. As required co-ordinate activities with *** Bio RA.
9. Assist the Manager in supporting and providing a service to other functions and departments (e.g. Clinical and Marketing).
任职要求:
1. Possesses a Bachelor degree in medicine, Biological or medical
2. Over 5 years regulatory affairs experience, and 2 years experience of assistant manager or manger
3. Have vaccine regulatory experience is preferred
4. Strong verbal and written communication skills.
5. Expert knowledge of regulatory policies and registration processes in China.
6. Excellent inter-personal skills.
7. Extensive and close contacts with KOLs and experts.
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