Essential Job Responsibilities:

• 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).

Qualifications:

• Possesses a Bachelor degree in microbiopharmaceutics.
  
• 3 years of regulatory work.
  
• Good 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.