Manager, GRA CMC & Devices Japan
Sanofi(7 months ago)
About this role
Senior regulatory professional accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global Regulatory CMC & Devices. Responsible for Japan CMC regulatory strategies, dossier preparation and approvals, and direct liaison with PMDA/MHLW. Acts as the Japan focal point collaborating with global CMC, R&D, manufacturing and quality teams and represents the company in regulatory policy and industry association activities.
Required Skills
- Regulatory Strategy
- CMC
- Dossier Preparation
- Health Authority Liaison
- Change Control
- Risk Assessment
- Regulatory Writing
- Project Management
- GMP
- Stakeholder Management
Qualifications
- Bachelor's Degree (Science/Health)
- Master's Degree
- PhD
About Sanofi
sanofi.comSanofi is a research & development-driven, AI-powered healthcare biopharma company committed to improving lives through innovative medicines & vaccines.
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