Principal Country Approval Specialist

PPD (Thermo Fisher)

UK
Not specified; not specified; not specified
8+ years regulatory experience
Country submission preparation
Local regulatory authority liaison
The Principal Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies

Job Summary

  • The Principal Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies.
  • This role serves as the primary contact for investigators and local regulatory authorities to ensure timely submission management and site activations.
  • Join a global team at Thermo Fisher Scientific that values passion, innovation, and a commitment to scientific excellence.

Matching Summary

The Principal Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 8+ years regulatory experience
  • Country submission preparation
  • Local regulatory authority liaison
  • Clinical trial site activation
  • Patient information sheet development

Nice-to-have

  • Mentoring junior team members
  • Strong negotiation skills
  • Excellent communication abilities
  • Team collaboration mindset
  • Strategic planning capabilities

Key Requirements

  • Bachelor's degree or equivalent
  • 8+ years relevant experience
  • Knowledge of EC and national regulations

Work Rights

Not specified

Tailored Resume

Cover Letter