Senior Regulatory Scientist

ICON Clinical Research, LP

Tokyo, Japan
Competitive salary; various annual leave entitleme...
**
Advanced degree in life sciences or pharmacy
3+ years regulatory affairs experience
Strong english communication skills
** ICON Clinical Research is seeking a Senior Regulatory Scientist in Tokyo or Osaka, Japan, to lead regulatory strategy and document preparation for global clinical development. This hybrid position requires substantial experience in regulatory affairs, strong communication skills, and a keen understanding of global regulations. **

Job Summary

  • The role involves leading regulatory strategy development and authoring complex documents for global clinical trial submissions.
  • Candidates must possess strong scientific writing skills and the ability to navigate complex regulatory landscapes including FDA and EMA guidelines.
  • ICON offers a competitive salary, diverse benefits including health insurance and retirement planning, and a culture focused on inclusion and well-being.

Matching Summary

Match Score: 75

** ICON Clinical Research is seeking a Senior Regulatory Scientist in Tokyo or Osaka, Japan, to lead regulatory strategy and document preparation for global clinical development. This hybrid position requires substantial experience in regulatory affairs, strong communication skills, and a keen understanding of global regulations. **

Salary

Competitive salary; Various annual leave entitlements; Health insurance and retirement planning offerings

Skills & Requirements

Must-have

  • Advanced degree in life sciences or pharmacy
  • 3+ years regulatory affairs experience
  • Strong English communication skills
  • Experience with FDA/EMA/ICH regulations
  • Health authority interaction experience

Nice-to-have

  • Mentoring junior regulatory staff
  • Copilot usage for literature research
  • CMC document creation experience
  • Client approach for new business
  • Cross-functional collaboration skills

Key Requirements

  • Advanced degree in life sciences, pharmacy, or medicine
  • Substantial experience in pharma, biotech, or CRO regulatory affairs
  • Business level English proficiency for global teams
  • Proficiency with Microsoft Word, Excel, and PowerPoint

Work Rights

Not specified

Tailored Resume

Cover Letter