Senior Regulatory Scientist

ICON Clinical Research, LP

Tokyo, Japan
Hybrid
Regulatory strategy development
Authoring regulatory documents
Health authority interactions
Provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions

Job Summary

  • Provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions.
  • Author and review complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.
  • ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance.

Matching Summary

Provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions.

Skills & Requirements

Must-have

  • regulatory strategy development
  • authoring regulatory documents
  • health authority interactions
  • clinical development regulations
  • scientific writing skills
  • Japanese regulatory affairs

Nice-to-have

  • foster an inclusive environment
  • nurtures talent
  • work life balance opportunities
  • Copilot literature search

Key Requirements

  • Advanced degree or equivalent regulatory experience
  • Substantial experience in regulatory affairs
  • 3+ years experience with regulatory authorities
  • Business-level English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter