1Write, sort out, review and submit the registration application materials such as drug registration, supplementary application and change, and cooperate with the drug regulatory department to handle relevant procedures in time according to the procedures; Track the progress of drug registration, so that the registration application can be approved smoothly;
2Be responsible for the contact with the registration department, drug inspection institution and evaluation center, track the registration progress, and grasp the registration information in time;
32. Through a variety of channels, grasp the drug registration policy and variety dynamics; or put forward administrative reconsideration and administrative litigation for unfair registration to safeguard the interests of enterprises;
41. Be responsible for searching the product characteristics, market information and literature materials of the varieties to be developed and registered; and be able to make a comprehensive analysis of the registration declaration status, market prospect, development cost and technical requirements of the proposed development;
5Write the research data and relevant documents of the corresponding work to meet the requirements of on-site inspection of drug registration;
6. Provide information support for enterprise sales, and timely feedback the comparison between the declared varieties and similar varieties in the market to the company's decision-making level.
1Bachelor degree or above, major in drug synthesis, pharmacy, drug analysis, more than 1 year experience in drug registration;
2Have a full understanding of the laws and regulations on drug registration management, and be familiar with the requirements of drug registration regulations and technical guidelines;
3Understand the process of generic drug research and development, have certain theoretical basis and practical experience in drug synthesis and drug analysis;
4Good communication and coordination skills. Familiar with the work flow of SFDA, drug testing institute, etc., and can communicate with them quickly and effectively;
5Good English listening, speaking, reading and writing skills and proficient use of computer office software.
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