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Ctry Approval Spec

Thermo Fisher Scientific · Beijing, China

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Role summary

Thermo Fisher Scientific seeks a Country Approval Specialist in Beijing to support clinical trial startup activities. The role involves preparing and coordinating local regulatory submissions, providing regulatory strategy advice, and managing country-level approval processes aligned with global submission timelines.

What they're looking for

  • Bachelor's degree or equivalent education
  • Knowledge of local regulatory requirements and submission processes
  • Experience with clinical trial regulatory submissions and approvals
  • Ability to coordinate with internal departments and external stakeholders
  • Proficiency in maintaining trial status databases and study files

What you'll be doing

  • Prepare, review, and coordinate local regulatory submissions for Ministry of Health and Ethics Committees
  • Provide regulatory strategy guidance to internal clients on country-specific approval pathways
  • Serve as key contact for ethical and regulatory submission-related activities at country level
  • Develop country-specific informed consent forms and patient information documents
  • Maintain accurate trial status information and study files according to company standards

Privacy & handoff

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What RoleLantern checked

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RoleLantern checkedNeeds clarity
Date posted6 days ago
Last source check1 day ago
Salary listedNeeds clarity
Location clearClear
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