Responsibilities: 1. Responsible for formulating product application plans, organizing and coordinating the writing and revision of drug application and registration documents, tracking the progress of drug registration, on-site audits, obtaining drug registration information in a timely manner, communicating and coordinating with relevant departments, and promoting the company's products to pass the approval of the national drug regulatory department ; 2. Have a comprehensive understanding of the development and application process and registration regulations of APIs and preparations, be able to independently handle or solve relevant problems in the process of drug application and registration, and have the ability to review application materials; 3. Responsible for the retrieval and translation of related drugs and literature; 4. Participate in the determination of the company's research and development projects and the provision of product information, put forward reasonable suggestions from the perspective of registration, and assist in clinical work related to registration; Job conditions: 1. Bachelor degree or above in medicine or pharmacy; 2. More than three years of drug registration experience and management experience in registration-related departments in large and medium-sized pharmaceutical companies, and those with imported drug registration experience are preferred; 3. Familiar with the relevant laws and regulations of API and preparation registration and relevant drug research guidelines, have the ability to organize and review application materials, and be able to manage and conduct registration of multiple drug projects at the same time; 4. Familiar with the drug registration application procedures and the requirements for various drug registration application materials, have strong writing skills, and be able to independently complete the compilation, arrangement and declaration of technical data; 5. Good communication, coordination, and independent thinking and problem-solving skills; 6. Good written and oral communication skills in English; |