Principal Regulatory Affairs Specialist (global Clinical Trial Applications)

PPD (Thermo Fisher)

UK
On-site
Global regulatory submissions (cta)
Client interfacing
Global regulatory projects for clinical trial applications
Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to join their global Regulatory Affairs team in the UK, focusing on clinical trial applications. The ideal candidate will possess extensive experience in regulatory submissions and project management within a clinical trial environment, with the opportunity for professional growth and development

Job Summary

  • Lead discussions and coordinate regulatory strategies globally on assigned clinical trials, studies and projects.
  • Provide innovative solutions and global regulatory expertise, acting as client interfacing to provide strategic regulatory intelligence and guidance.
  • Act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to join their global Regulatory Affairs team in the UK, focusing on clinical trial applications. The ideal candidate will possess extensive experience in regulatory submissions and project management within a clinical trial environment, with the opportunity for professional growth and development.

Skills & Requirements

Must-have

  • Global regulatory submissions (CTA)
  • Client interfacing
  • Global regulatory projects for Clinical Trial Applications
  • ICH and other global regulatory guidelines

Nice-to-have

  • Client interaction and liaison
  • Business development support
  • Quality improvement initiatives
  • Award-winning learning and development programme

Key Requirements

  • 8+ years of experience
  • Bachelor's degree or advanced degree preferred
  • Knowledge of the global clinical trials landscape
  • Experience with Bid Defense meetings

Work Rights

Not specified

Tailored Resume

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