招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
Major Accountabilities
? 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
Ideal Background
Education:
Must Have:Bachelor’s degree or upwards with medical / pharmaceutical major is required.
Languages:
Excellent verbal and written communication & presentation skills in English
Experience/Professional Requirement:
3- 5 years of regulatory experience in multi-national pharmaceutical industry.
Ability to work cross functional and business teams, good communication and interpersonal skills that can influence decision-making in a professional manner.
年薪15-20万
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