Senior Regulatory Affair Specialist - Global Clinical Trial Applications

Thermo Fisher Scientific UK

United Kingdom
On-site
Global regulatory submissions
Interacting with sponsors
Review clinical trial documents
Thermo Fisher Scientific is seeking a Senior Regulatory Affairs Specialist to support global clinical trial applications. The role involves leading regulatory strategies for clinical trials and providing strategic regulatory intelligence while working in a collaborative team environment

Job Summary

  • You will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects.
  • You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.
  • As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Senior Regulatory Affairs Specialist to support global clinical trial applications. The role involves leading regulatory strategies for clinical trials and providing strategic regulatory intelligence while working in a collaborative team environment.

Skills & Requirements

Must-have

  • global regulatory submissions
  • interacting with sponsors
  • review clinical trial documents
  • review scientific literature
  • manage project teams
  • client interfacing
  • global clinical trial applications

Nice-to-have

  • experience with bid defense meetings
  • innovative solutions
  • flexible working culture

Key Requirements

  • Bachelor's degree or advanced degree preferred
  • Previous experience that provides the knowledge, skills, and abilities to perform the job
  • Knowledge of the global clinical trials landscape
  • Excellent command of the English language
  • Excellent attention to detail
  • Exceptional interpersonal skills
  • Advanced computer skills
  • Strong organizational, time management, and planning skills
  • Capable of working independently
  • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization
  • Expert knowledge of ICH and other global regulatory guidelines
  • Excellent analytical, investigative and problem-solving skills

Work Rights

Not specified

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