Senior Global Regulatory Scientist

ICON plc

Sofia, Bulgaria
Regulatory affairs experience
Global regulatory frameworks
Clinical development regulatory strategy
Support the development, implementation, and execution of regulatory strategies for clinical development programmes

Job Summary

  • Support the development, implementation, and execution of regulatory strategies for clinical development programmes.
  • Prepare, review, and coordinate regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
  • ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities.

Matching Summary

Support the development, implementation, and execution of regulatory strategies for clinical development programmes.

Skills & Requirements

Must-have

  • Regulatory affairs experience
  • Global regulatory frameworks
  • Clinical development regulatory strategy
  • Health authority interactions
  • Regulatory document preparation

Nice-to-have

  • Cross-functional team collaboration
  • Adaptability to regulatory changes
  • Innovation and excellence culture
  • Well-being and work-life balance

Key Requirements

  • Bachelor's degree in scientific or healthcare field
  • Experience in regulatory affairs, writing, or clinical development
  • Understanding of global regulatory guidelines
  • Strong scientific and analytical skills
  • Excellent communication and attention to detail
  • Ability to manage multiple timelines
  • Willingness to travel approximately 5%

Work Rights

Not specified

Tailored Resume

Cover Letter