Ctry Approval Spec

Thermo Fisher Scientific UK

Remote, United Kingdom
Regulatory submissions to eu ctis
Local regulatory strategy advice
Contact with investigators
Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy

Job Summary

  • Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy.
  • Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.

Matching Summary

Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy.

Skills & Requirements

Must-have

  • regulatory submissions to EU CTIS
  • local regulatory strategy advice
  • contact with investigators
  • country level contact
  • align with submissions activities
  • maintain trial status information

Nice-to-have

  • gene therapy approvals
  • develop country specific documents
  • maintain local country study files

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter