Ctry Approval Spec

PPD (Thermo Fisher) UK

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Regulatory submissions to eu ctis
Local regulatory strategy advice
Trial status information maintenance
** PPD (Thermo Fisher) UK is seeking a Country Approval Specialist to prepare and coordinate regulatory submissions, primarily for EU Clinical Trial Information System (CTIS) and other local applications. The role involves working closely with internal teams and ensuring alignment of submissions with site activation timelines while maintaining compliance with regulatory guidelines. **

Job Summary

  • The role involves preparing and reviewing regulatory submissions in alignment with global strategies.
  • You will provide local regulatory strategy advice to internal clients and coordinate with various departments.
  • Maintaining knowledge of current regulatory guidelines is essential for success in this position.

Matching Summary

Match Score: 75

** PPD (Thermo Fisher) UK is seeking a Country Approval Specialist to prepare and coordinate regulatory submissions, primarily for EU Clinical Trial Information System (CTIS) and other local applications. The role involves working closely with internal teams and ensuring alignment of submissions with site activation timelines while maintaining compliance with regulatory guidelines. **

Skills & Requirements

Must-have

  • regulatory submissions to EU CTIS
  • local regulatory strategy advice
  • trial status information maintenance

Nice-to-have

  • contact with investigators
  • knowledge of PPD SOPs
  • experience with gene therapy approvals

Key Requirements

  • Bachelor's degree or equivalent
  • 2+ years of relevant experience

Work Rights

Not specified

Tailored Resume

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