Principal Reg Affairs Spec

Thermo Fisher Scientific UK

Remote
**
Global regulatory strategies
Client interfacing
Regulatory intelligence and guidance
** Thermo Fisher Scientific UK is seeking a Principal Regulatory Affairs Specialist to join their remote team. The role involves leading global regulatory strategies for clinical trials, providing regulatory guidance, and collaborating with internal and external stakeholders. **

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 interface for strategic regulatory intelligence and guidance.
  • Act as a representative of the regulatory department with other departments, supporting business development and contributing to quality improvement.

Matching Summary

Match Score: 75

** Thermo Fisher Scientific UK is seeking a Principal Regulatory Affairs Specialist to join their remote team. The role involves leading global regulatory strategies for clinical trials, providing regulatory guidance, and collaborating with internal and external stakeholders. **

Skills & Requirements

Must-have

  • Global regulatory strategies
  • Client interfacing
  • Regulatory intelligence and guidance
  • Global regulatory submissions
  • ICH and global regulatory guidelines
  • English language proficiency

Nice-to-have

  • Experience with bid defense meetings
  • Innovative solutions
  • Quality improvement initiatives

Key Requirements

  • Bachelor's degree or advanced degree preferred, or equivalent
  • Previous experience in regulatory affairs
  • Knowledge of global clinical trials landscape
  • Advanced computer skills
  • Strong organizational, time management, and planning skills
  • Ability to work independently and exercise judgment

Work Rights

Not specified

Tailored Resume

Cover Letter