Senior RA manager/Associate RA Director
- 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).
- Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and GSK requirements.
- Ensure that GSK Bio. Regulatory Affairs are kept fully informed on the current regulatory status of all assigned products.
- Ensure that Import product labeling and PI is consistent with SDA guidelines and requirements.
- Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to SFDA.
- Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with SFDA and GSK requirements.
- 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.
- As required co-ordinate activities with GSK Bio RA.
- Assist the Manager in supporting and providing a service to other functions and departments (e.g. Clinical and Marketing).
5.When the job holder becomes the member of QMS Implementation Team, she/he is responsible for her/his assigned supporting work.
1.Preparing and submitting the documentation for new registrations and renewal of existing regulatory approvals for finished product imports. Current scope includes:
- Import :
- Current products IDL renewal and its variation
- New products registration
- Localization: Repackaging license and its renewal
2.Commercial supplying: to trace all commercial goods CoAs from NICPBP
3.Cooperate with GSKBS GMP certificate
- Regulation search and distribute to relevant parties internally
- Involve in regulation influence activities
- Involve in related industry regulatory activities
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