Principal Regulatory Affairs Specialist (global Clinical Trial Applications)

PPD (Thermo Fisher)

UK
Competitive salary; not specified; extensive benef...
8+ years experience in global clinical trials
Preparation of global regulatory submissions cta
Expert knowledge of ich and global guidelines
This role involves leading discussions and coordinating regulatory strategies globally on assigned Phase 1 to 4 clinical trials

Job Summary

  • This role involves leading discussions and coordinating regulatory strategies globally on assigned Phase 1 to 4 clinical trials.
  • The company offers an award-winning learning and development programme alongside a competitive salary and extensive benefits package.
  • As part of a global team at PPD, you will act as a representative of the regulatory department supporting business development initiatives.

Matching Summary

This role involves leading discussions and coordinating regulatory strategies globally on assigned Phase 1 to 4 clinical trials.

Salary

Competitive salary; Not specified; Extensive benefits package based on health and well-being

Skills & Requirements

Must-have

  • 8+ years experience in global clinical trials
  • Preparation of global regulatory submissions CTA
  • Expert knowledge of ICH and global guidelines
  • Experience with bid defense meetings
  • Excellent English written and oral communication

Nice-to-have

  • Strong interpersonal skills for team collaboration
  • Ability to work independently with judgment
  • Advanced computer skills including Microsoft Office
  • Flexible working culture appreciation
  • Commitment to quality and accuracy

Key Requirements

  • Bachelor's or advanced degree preferred
  • 8+ years comparable experience
  • Knowledge of global clinical trials landscape
  • Expert understanding of country requirements

Work Rights

Not specified

Tailored Resume

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