Principal Reg Affairs Spec

Thermo Fisher Scientific UK

Global regulatory submissions preparation
Clinical trial document review and assessment
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 between internal departments, external clients, and regulatory agencies.
  • Responsibilities include preparing global regulatory submissions, reviewing scientific literature, and managing project timelines.

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 document review and assessment
  • ICH and global regulatory guidelines knowledge
  • English language proficiency written and oral
  • Project team management and coordination

Nice-to-have

  • Experience with bid defense meetings
  • Strong editorial and proofreading skills
  • Excellent interpersonal communication skills
  • Independent judgment in assessing needs
  • Adaptability to changing priorities

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