인재풀 - Country Approval Specialist (SSU)

Thermo Fisher Scientific · Republic Of, South Korea

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Role summary

Thermo Fisher Scientific seeks a Country Approval Specialist to manage clinical trial regulatory submissions and coordinate with local authorities in Korea. This evergreen talent pool position supports PPD's clinical operations team across study approval processes.

What they're looking for

Bachelor's degree or equivalent relevant formal qualification
2+ years of experience in regulatory submissions or clinical operations
Excellent written and oral English communication skills
Strong knowledge of Korean and regional regulatory guidelines
Proficiency with regulatory databases and submission software
Medical terminology and therapeutic area knowledge
Strong attention to detail and documentation quality

What you'll be doing

Prepare, review, and coordinate local regulatory submissions with global strategy alignment
Serve as primary contact with investigators and Korean regulatory authorities for submission management
Develop and implement country-specific submission strategy with technical oversight
Coordinate site start-up activities with submissions to meet critical activation timelines
Maintain trial status information and country study files per company and client standards

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Date posted2 days ago

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