Country Approval Specialist
Thermo Fisher Scientific · Remote
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Thermo Fisher Scientific seeks a Country Approval Associate to support preparation, review, and coordination of regulatory submissions for clinical trial sites. This remote role in India involves managing local submissions aligned with global strategy, coordinating with internal departments, and maintaining regulatory compliance documentation.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 0 to 2 years of relevant experience in regulatory or submission-related work
- Effective written and oral communication skills
- Strong attention to detail and quality documentation
- Basic knowledge of regional and national regulatory guidelines
- Proficiency with computer systems and ability to learn new software
- Basic understanding of medical terminology and therapeutic concepts
What you'll be doing
- Prepare, review, and coordinate local ethics committee and ministry submissions under guidance
- Coordinate with internal departments to align site start-up activities with submission timelines
- Develop and maintain regulatory compliance review packages and country study files
- Assist in preparing patient information sheets, informed consent forms, and grant budgets
- Maintain trial status information in tracking databases and ensure adherence to standard operating procedures
Privacy & handoff
This role links to Thermo Fisher Scientific's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.