北京招聘

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).

• 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 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.

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