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Drug registrar
Work location
Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai
Job type
Management position
Job responsibilities
1. Familiar with the requirements of drug registration and application at home and abroad, responsible for writing, summarizing and sorting technical data, completing the internal writing, review and revision of application data and filing of registration data;
2. Responsible for following up and learning national policies and regulations related to drugs, monitoring registration regulations and competitive product information;
3. Responsible for clinical trial application, listing registration application, re-registration application and supplementary application of products;
4. Daily follow up of products under research and provide regulatory support;
5. Responsible for communicating with the drug regulatory authorities and promoting the registration and declaration process
6. Participate in government project application
7. Assist leaders to complete relevant work
Qualification
1. Bachelor degree or above, major in chemistry, pharmacy, pharmaceutical engineering, etc
2.2 At least years of work experience in drug registration, with experience in writing application materials and the ability to review application materials
3. Familiar with domestic and foreign drug regulations and product registration procedures
4. Good English reading and writing skills, able to translate English literature
5. Have good communication and coordination skills, good reading comprehension and writing skills