职位描述
Job Purpose:
To assist and support line manager in executing/implementing the Company’s regulatory strategy plan and to deliver contribution to the agreed regulatory objectives
Essential Job Responsibilities:
Establish, maintain and develop good relationships with China HA, to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).
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 Chinese guidelines and requirements.
Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to China HA.
Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with China HA 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).
Qualifications:
· Possesses a Bachelor degree in medicine, Biological or medical
· Over 5 years regulatory affairs experience, and 2 years experience of assistant manager or manger
· Have vaccine regulatory experience is preferred
· Strong verbal and written communication skills.
· Expert knowledge of regulatory policies and registration processes in China.
· Excellent inter-personal skills.
· Extensive and close contacts with KOLs and experts.
