Country Approval Specialist

Thermo Fisher Scientific

Shanghai, China
**
Local regulatory submissions
Country-level regulatory advice
Site start-up coordination
** Thermo Fisher Scientific is seeking a Country Approval Specialist in Shanghai, China, to manage and prepare regulatory submissions for clinical trials. The ideal candidate will have a bachelor's degree, relevant experience, and strong communication skills to ensure compliance with local regulations. **

Job Summary

  • As a Country Approval Specialist, you will support study startup by participating in the management and preparation, review and coordination of country submissions in line with global submission strategy.
  • Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
  • We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Matching Summary

Match Score: 75

** Thermo Fisher Scientific is seeking a Country Approval Specialist in Shanghai, China, to manage and prepare regulatory submissions for clinical trials. The ideal candidate will have a bachelor's degree, relevant experience, and strong communication skills to ensure compliance with local regulations. **

Skills & Requirements

Must-have

  • Local regulatory submissions
  • Country-level regulatory advice
  • Site start-up coordination
  • Company SOPs and guidelines

Nice-to-have

  • Effective communication skills
  • Strong attention to detail
  • Ability to work independently

Key Requirements

  • Bachelor's degree or equivalent
  • 2+ years of relevant experience
  • Basic medical/therapeutic area knowledge
  • Basic knowledge of regulatory guidelines

Work Rights

Not specified

Tailored Resume

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