Job Description
**Role & Responsibilities**
The R&D Regulatory Affairs has responsibility for managing products under development and/or
marketed products with new indications.
• Develop regulatory strategy for new drug developments, Health Authority meetings and Japan
New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for
products under development and/or marketed products,
• Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and
arrange the internal review of J-CTD,
• Lead the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA
Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any
type of responses document to Health Authority questions with the stakeholders (Non- clinical,<...
The R&D Regulatory Affairs has responsibility for managing products under development and/or
marketed products with new indications.
• Develop regulatory strategy for new drug developments, Health Authority meetings and Japan
New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for
products under development and/or marketed products,
• Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and
arrange the internal review of J-CTD,
• Lead the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA
Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any
type of responses document to Health Authority questions with the stakeholders (Non- clinical,<...
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