Regulatory Manager-Oncology 注册经理 -上海/北京

Major Responsibilitie********

 Take the responsibility for implementing an******** regulatorysubmission an******** an******** for products / projects withinagree********. Ensure regulatory compliance with government policyan******** require********
 Establish an******** close relationship with SFDA/ CDE/ NICPBPan******** appropriate regulatory agencies an******** manager’s guidancehave a close/ effective communication with relevant regulatory agenciesto consult regulatory strategy, determine status an******** theapprovals of applications submitte******** SFDA.
 Conduct scientific discussion with relevant external an********scientific functions locally an********, spec******** global CMCan******** Operat******** Pharmaceutical Development, Pre-Clinical etc.
 Maintain goo******** in general/product specific scientific an********requiremen******** process
 Maintain strong working relationship an******** with cross-functionsto provide regulatory information an********.
 Provide support to Policy & Intelligent management or Database******** update an******** an******** execution.

Qualification Requiremen********

• University graduate ; Pharmacy, Medical or Master or PhD inbiopharmaceutical relevant subject preferred
• Working Experience:
• Goo******** knowledge an******** in Regulatory in Chinese regulationan******** knowledge in international regulat******** asevidence******** working minimum 6 years in the MNC pharmaceuticalindustry. Able to demonstrate leadership in managing cross functionproject independently for at least single simultaneous globaldevelopment project in China successfully. Or demonstrate goo********judgment in research an******** environment by working or study at least8 years in the global research or development laboratory or appropriategraduate study.
• Demonstrate the ability to discuss new development strategic forspecial topics or TA of responsibility
• Demonstrate global regulatory working experiences in responsible formanaging regulatory activities.
• Comprehensive understanding of global/China registration an********.
• Goo******** planning an******** skill
• Excellent subjec******** leadership an******** cross-functionalcoordination ability will be desired.
• Special value or performance award, honor earne******** to R&Dachievement earne******** or externally will be considere********additional experiences.
• Goo******** of China registration an********
• Goo******** skill in English an********
• Excellent negotiating skills
• Computer literacy with standar********
• Willing to frequent traveling if base******** SH
• Personal Attribute********
• Ability to plan an******** projects effectively
• Ability to work independently an******** self motivation
• Ability to manage competing priorities an******** driving
• Excellent team player attitude.