Deputy General Manager, Director, Manager and Commissioner of drug registration and application

文章附图

Job description


1.Responsible for the organization, management and coordination of the company's new drug declaration;

2.Familiar with the domestic new drug declaration regulations and procedures, especially the biomedical drug declaration regulations;

3.Be familiar with the collation and compilation of the application materials, and be able to put forward and correct the existing problems in the application materials in a timely manner;

4.To ensure that the drug declaration information is comprehensive, complete, authentic and reliable;

5.Timely collect, classify, sort out and file the regulations, documents and technical data issued by the state administration department;

6.To undertake the task of publicizing drug regulatory policies and regulations, and to provide information on drug regulatory policies and regulations to all departments;

7.To provide information support for the enterprise decision makers, timely report the comparison between the declared varieties and the similar varieties in the market to the enterprise decision makers.


   Job requirements


1.Bachelor degree or above in pharmacy or related field;

2.At least 2 years related work experience, with pharmaceutical company registration and application, especially with background of biomedical application is preferred;

3.Has the strong registration information retrieval and the analysis ability, has the problem solving experience and thought;

4.Good communication and interpersonal skills, excellent team work spirit; Good communication with CDE and cFDA;

5.Strong writing ability.

Share to: