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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: 
China

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
Thermo Fisher Scientific logo
Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com
10001 Employees
HQ: Waltham
About Thermo Fisher Scientific
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
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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.

Hard Skills

Regulatory FilingsDocument PreparationsRegistrationContinuing Medical Education

Other Skills

  • Communication
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