1.Write, organize and submit the registration and declaration information of drug registration, supplementary application, change and so on, and cooperate with the drug regulatory department in a timely manner with the relevant procedures in accordance with the procedures.
2.To assist in the completion of the declaration project implementation platform on-site verification, production approval declaration and verification work.
3.Track the progress of registration, timely grasp of registration information, report the registration progress and related departmentfeedback information, and propose solutions.
4.Responsible for collecting and organizing relevant policies and regulations on drug registration, establishing and updating the relevant policy and regulatory information base, and doing a good job in the relevant training of various departments.
5. Participate in the project of pre-research and research and development, search product characteristics, market information, literature and other materials for the proposed development of registered products, and provide reference opinions for the registration and declaration of the company's products.
1.Be familiar with biomedicine, immunocellular therapy research and development and production expertise.
2.Learn about GMP, GCP, AND GLP.
3.Be familiar with CDE, CFDA regulations, understand ICH, FDA, EMA related regulations.
4.Strong coordination, communication, expression skills, strong executive and team work ability.
5. Good writing (Chinese) skills and English skills