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Clinical Trial Reg Affairs Specialist III

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Clinical Trial Reg Affairs Specialist III

Beijing, China

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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Good communications skill

Client-provided location(s): Beijing, China
Job ID: ThermoFisher-R-01288880
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program