SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

To conduct all the necessary registration procedures in order to ensure the new product registration in China ,post -marketing change management  as well as the sales of vaccine products in China have received the relevant government approvals and licenses. These registration procedures apply to the following activities:

ž   New product registration. Including clinical trial application and permits as well as the marketing authorization license application and approval；

ž   Life cycle management of marketed products. Including license renewal and post -marketing change management ;

KEY ACCOUNTABILITIES

1．Registration new product in China

2．To conduct within the company budget and timeframe the process of certificate renewal, and supplementary registration and ensure the ongoing validity of these certificates.

3．To coordinate with other departments such as Medical and Marketing Department during the registration process to share necessary information for registration.

4．To maintain efficient and durable relationships with government authorities such as NMPA, NIFDC, PDA, CDE to ensure a smooth registration process.

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