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Clinical Trial Reg Affairs Specialist III

Location Beijing, Beijing, China Job Id R-01305502 Job Type Full time Category Clinical Research Remote Fully Onsite
Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO). 
JOB DESCRIPTION

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

Good communications skill

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