Principal Reg Affairs Spec

PPD (Thermo Fisher)

UK
Global regulatory submissions preparation
Clinical trial regulatory document review
Ich and global regulatory guidelines knowledge
This role serves as a pivotal team member leading global regulatory strategies for Phase 1 to 4 clinical trials

Job Summary

  • This role serves as a pivotal team member leading global regulatory strategies for Phase 1 to 4 clinical trials.
  • The successful candidate will act as a liaison with internal and external clients while providing strategic regulatory intelligence.
  • Responsibilities include arranging, leading, and reporting on client and regulatory agency meetings.

Matching Summary

This role serves as a pivotal team member leading global regulatory strategies for Phase 1 to 4 clinical trials.

Skills & Requirements

Must-have

  • Global regulatory submissions preparation
  • Clinical trial regulatory document review
  • ICH and global regulatory guidelines knowledge
  • English language proficiency
  • Project team management

Nice-to-have

  • Bid defense meeting experience
  • Scientific literature assessment skills
  • Client interfacing capabilities
  • Business development support
  • Quality improvement initiatives

Key Requirements

  • Bachelor's or advanced degree preferred
  • Knowledge of global clinical trials landscape
  • Expert knowledge of ICH guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter