Sr. Ctry Approval Spec (CAS-EC)
Thermo Fisher Scientific · Republic Of, South Korea
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Senior Country Approval Specialist at Thermo Fisher Scientific responsible for managing regulatory submissions and strategy coordination across country health ministries and ethics committees. The role involves preparing submission documentation, advising on regulatory strategy, and serving as the primary contact for local authorities and internal stakeholders in Seoul.
What they're looking for
- Excellent knowledge of regional and national regulatory guidelines and ethics committee regulations
- Effective oral and written communication skills with strong attention to detail
- Experience managing regulatory submissions to health ministries and ethics committees
- Good negotiation and interpersonal skills with ability to work independently
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Proficiency with computer systems and ability to learn regulatory software
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions aligned with global strategy
- Provide regulatory strategy advice to internal clients and serve as primary contact for investigators and authorities
- Develop and implement local submission strategy with technical expertise and project coordination oversight
- Maintain country study files and ensure compliance with standard operating procedures and regulatory guidelines
- Direct and mentor other regulatory team members assigned to supported projects as appropriate
Privacy & handoff
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