1.Develop and implement registration strategy for new diagnostics, medical devices & therapeutic biologicals and maintain for post-market products in align with the growth strategy of portfolio in China.2.Provide regulatory expertise to support business of the company.3.Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency. 4.Conduct in compliance with local regulatory agency requirements as well as relevant company policy and internal SOP.

1. Develop registration strategy and manage registration for new products, license renewal and variations to post-market products and ensure optimal regulatory support to product lifecycle management for business objectives.2. Ensure successful implementation of registration strategy and high quality of filing dossiers.3. Set up necessary process & infrastructure and monitor the overall review process and response to the additional data request or queries from regulatory authorities to ensure the set registration strategy and timeline being implemented in a timely manner.4.Lead project team for oversea site inspection for GMP & registration by HA, site change of all products and etc.5. Involve in task force to solve issues of products on ChP 2010 and draft monograph of products which will be added in ChP2015.

1. Lead to Develop and enhance the culture of R&D center, policies, SOPs and responsibility related to Research, Regulation Affairs, Government Affairs and Administration functions.2. Set up necessary process & infrastructure and monitor the overall review process and response on Research and development to ensure the set reseach and registration strategy and timeline being implemented in a timely manner. 3. Ensure successful implementation of registration strategy and high quality of filing dossiers and manage registration submission for the products below(CTA):  EV71+Hep A combo vaccine, Universal Influenza vaccine, pneumococcal conjugate vaccine (13 valent), pneumococcal polysaccharides vaccine (23 and 24 valent).

1.Maintain for post-market products:Hepatitis A Vaccine, Hepatitis A and B combine Vaccine, Flu Vaccine.2.Registration for new products: a. The following products handled by me have obtained the production license:Category 1: Pandemic Influenza Vaccine (whole/split Viron), H1N1 vaccine (Special Regulatory Procedure)b. The following products handled by me have obtained the approval of clinical trials:EV71 vaccine (Category 1), H1N1 vaccine (Special Regulatory Procedure), JE vaccine, Recombinant Hep B vaccine (yeast). 3.All external affairs which need to communicate and cooperate with Health Authorities: such as GMP of China, License for Manufacturing and etc..4.Apply for the project funds from governments or other organizations, such as Bill Gates Fund and etc.