SSU
Thermo Fisher Scientific · Shanghai, China
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Role summary
Thermo Fisher Scientific seeks a regulatory specialist to manage local submissions and coordinate site activation for clinical trials in Shanghai. The role involves preparing regulatory documentation, providing local strategy advice, and ensuring compliance with global submission timelines.
What they're looking for
- Proven experience in regulatory submission processes
- Outstanding organizational and coordination skills
- Strong communication abilities with investigators and internal stakeholders
- Meticulous attention to detail and quality focus
- Ability to collaborate in ambitious, innovative environments
What you'll be doing
- Prepare and review local regulatory submissions under mentorship aligned with global strategies
- Provide regulatory strategy guidance to internal clients at country and Ministry of Health levels
- Coordinate site start-up activities to meet submission timelines and activation targets
- Develop and maintain country-specific informed consent forms and patient information documents
- Manage trial status data entry and maintain study files per company and client 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.