Senior RA manager/Associate RA Director

Your Responsibilities:
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

4. Regulatory Affairs:
• Regulation search and distribute to relevant parties internally
• Involve in regulation influence activities
• Involve in related industry regulatory activities

• 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).


Why You?

Basic 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.


Preferred qualifications:

Why GSK?:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

Contact information:
You may apply for this position online by selecting the Apply now button.
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