About this role
Job title: Manager, Regulatory Affairs
• Location: Tokyo
About the job 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.