Clinical Trial Reg Affairs Specialist III

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Responsibilities:

Be responsible for the registrations of imported drug. Including but not limited to the good communications with NMPA, CDE and other authority, registration documents preparation, performing the test, documents submissions and follow up of NMPA until get the approval. Timely documents archiving. Other tasks if needed.

Minimum Qualifications: Bachelor degree

At least 2-3 year's experience on imported drug registration

Good at written and oral English

Preferred Qualifications: Medical education background

The experience on all of API, ANDA, IND and other type registration is preferred

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