Regulatory Project / Products
Sanofi(2 months ago)
About this role
An R&D Regulatory Affairs professional at Sanofi provides regulatory expertise for drug development and lifecycle activities in Japan, supporting submissions and interactions with health authorities. The role partners with cross‑functional project teams to ensure compliance and strategy for products under development and marketed products with new indications.
Required Skills
- Regulatory Strategy
- J-CTD
- Clinical Submissions
- Health Authority Meetings
- Risk Management
- Stakeholder Collaboration
- Package Insert Revision
- Negotiation
- Communication
- Japanese
Qualifications
- At Least 2 Years Regulatory/R&D Experience
- Native Level Japanese
- TOEIC 800
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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