1. Be responsible for communicating with entrusted research company, following up the study progress, and supervising the research company’s work and raising technical requirements according to the requirements of real-time registration regulations;
2. Be responsible for compiling a part of application data, reviewing the registration data compiled by the entrusted research company, and feeding back and supervising the modification of such data;
3. Be responsible for sorting and handing in the registration data, tracking the progress of registration, and timely feeding back and coordinating the solving of review and approval issues;
4. Organize communication with CDE as required, and compile and submit communication data to CDE;
5. Be responsible for international registration management of existing projects, comprehend and learn international registration requirements, communicate with registration agencies, and track and manage registration affairs;
6. Timely track, get familiar with and interpret the relevant laws and regulations related to drug research of NMPA and CDE, search the dynamic progress of industry regulations, and offer training and policy support to the drug study teams.
1. Be familiar with the whole process of drug R&D and regulations related to drug registration;
2. Good communicating and coordinating ability, meticulous and patient working attitude, and active and initiative professional dedication;
3. Have more than 5 years’ work experience in drug registration application, and good connections for drug registration. Those with work experience for registration management in large pharmaceutical companies are preferred;
4. Good Chinese and English writing ability. Those with English reading ability are preferred;
5. Those who have the experience of submission of CTD data to ANDA or NDA and successfully acquired approvals are preferred.