Prepare the registration submission for CTA, NDA, license renewal and variation according to SFDA requirements and company plan
·Ensure the new products application, license renewal and variations registration are managed according to the timeline specified in the reporting period.
·Assist RA Manager to set up registration strategy and registration plan for each application.
·Double check registration dossiers to ensure them meet both SFDA requirements and CDE guidance
·Monitor the whole registration process to ensure the process going smoothly
·Registration status feeding back timely from both SFDA testing labs and CDE to accelerate registration process
·Be aware of government regulation & human resources change in advance to prevent unfavorable decision which will impact new product launch and marketed product
·Get involvement in Product Launch Velocity to assist marketing launch the product in China
·Assist distributor to resolve the on-port testing for drugs and other related issues
·Closely work with global & regional regulatory personnel to ensure the clear & smooth communication & request
·Maintain the close working relationship with SFDA, testing labs and other government agencies
·Keep Marketing/Sales team updated with regulatory status to become a business partner
·Assist Marketing/Sales team for post market surveillance, products promotion and market support

在全球75个国家和地区设有分公司，拥有15,000多名员工，5 个研发中心，14个生产工厂，产品销售遍及180多个国家和地区