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Clinical Trial Reg Affairs Specialist III

extra holidays - extra parental leave
Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Bachelor degree, 2-3 years experience in drug registration.

Key responsabilities:

  • Responsible for registrations of imported drugs
  • Prepare documentation and communicate with NMPA
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Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com
10001 Employees
HQ: Waltham
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Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Communication

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