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International drug registrar

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2018/09/29 08:15
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Job Responsibilities:
 
1. Responsible for the writing and finishing of the company's API products in the United States, the European Union and other countries and regions;
 
2. From the beginning of the small test to the project declaration, keep in touch with the company's project research and development department, and track and supervise the progress of the project;
 
3. Master drug registration policies and variety dynamics through various channels, and handle drug registration in a timely manner;
 
4. Master the requirements of CDE for registration materials, and understand the relevant guidelines for ICH and FDA registration of drugs;
 
5. Have good communication skills, organizational and coordination skills and teamwork awareness.
 
job requirements:
 
1. Bachelor degree or above in pharmacy, biopharmaceutical, etc., more than one year relevant work experience;
 
2. Familiar with drug registration process and excellent English writing ability;
 
3. Familiar with the requirements of laws and regulations related to drug registration, and provide policy support for new product projects.
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