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Thermo Fisher Scientific is seeking a Country Approval Specialist to manage and coordinate regulatory submissions for clinical trials. The role requires effective communication, attention to detail, and knowledge of regulatory guidelines, alongside a bachelor's degree and at least two years of relevant experience.
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Job Summary
The role involves preparing, reviewing, and coordinating local regulatory submissions including MoH and Ethical Committee approvals in alignment with global strategies.
Candidates will serve as the key contact at the country level for ethical or regulatory activities and coordinate site start-up activities to meet critical path timelines.
The position requires maintaining accurate trial status information in tracking databases and ensuring local study files comply with PPD SOPs and client directives.
Matching Summary
Match Score: 75
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Thermo Fisher Scientific is seeking a Country Approval Specialist to manage and coordinate regulatory submissions for clinical trials. The role requires effective communication, attention to detail, and knowledge of regulatory guidelines, alongside a bachelor's degree and at least two years of relevant experience.
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Skills & Requirements
Must-have
Bachelor's degree or equivalent
2+ years relevant experience
Local regulatory submission preparation
Ethical committee and MoH knowledge
Strong attention to detail
Nice-to-have
Excellent interpersonal communication skills
Good negotiation abilities
Team collaboration in global environment
Basic medical terminology knowledge
Key Requirements
Bachelor's degree required
Minimum 2 years of relevant experience
Knowledge of regional/national regulatory guidelines