Ctry Approval Spec

Thermo Fisher Scientific UK

Unknown, Unknown, United Kingdom
Standard office hours (40 hours/week)
Eu ctis regulatory submission preparation
Local regulatory strategy advice to clients
Site start-up activities coordination
Thermo Fisher Scientific UK is seeking a Country Approval Specialist to manage regulatory submissions related to clinical trials, ensuring alignment with global strategies and local regulatory requirements. The role involves coordinating with various internal departments and maintaining compliance with submission processes while supporting investigators in submission-related activities

Job Summary

  • The role involves preparing and coordinating regulatory submissions to EU CTIS and national local applications under global strategy guidance.
  • Candidates will serve as the key contact at the country level for ethical or regulatory submission-related activities while ensuring alignment with site activation timelines.
  • The position requires maintaining accurate trial status information in tracking databases and developing country-specific patient documentation.

Matching Summary

Match Score: 75

Thermo Fisher Scientific UK is seeking a Country Approval Specialist to manage regulatory submissions related to clinical trials, ensuring alignment with global strategies and local regulatory requirements. The role involves coordinating with various internal departments and maintaining compliance with submission processes while supporting investigators in submission-related activities.

Skills & Requirements

Must-have

  • EU CTIS regulatory submission preparation
  • local regulatory strategy advice to clients
  • site start-up activities coordination
  • patient information sheet development
  • clinical trial status database entry

Nice-to-have

  • experience with gene therapy approvals
  • contact with investigators for submissions
  • alignment of critical path timelines
  • collaboration with start-up CRAs

Key Requirements

  • Bachelor's degree or equivalent qualification
  • 2+ years of relevant experience
  • Knowledge of PPD SOPs and client directives

Work Rights

Not specified

Tailored Resume

Cover Letter