Regulatory Manager

Sanofi UK

Hatsudai, Tokyo, Japan
Japan regulatory cmc strategies
Pmda/mhlw liaison experience
Regulatory dossier preparation
The incumbent is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices

Job Summary

  • The incumbent is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices.
  • Responsibilities include developing innovative regulatory CMC strategies, managing direct contact with PMDA/MHLW, and leading quality consultations.
  • The role requires ensuring submission dossiers meet quality standards while collaborating with global teams to achieve optimal solutions for technical issues.

Matching Summary

The incumbent is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices.

Skills & Requirements

Must-have

  • Japan regulatory CMC strategies
  • PMDA/MHLW liaison experience
  • Regulatory dossier preparation
  • Post-marketed change controls
  • Health authority negotiations

Nice-to-have

  • Mentoring and training staff
  • Experience with Health Authority
  • Global operational experience
  • Technical pharmaceutical CMC background

Key Requirements

  • Bachelor's degree in science/health field
  • Minimum 3 years Regulatory CMC experience
  • Business level English fluency required

Work Rights

Not specified

Tailored Resume

Cover Letter