Country Regulatory Specialist

About the role

Syneos Health is hiring a Country Regulatory Specialist in Tokyo, working in a hybrid setting. The role provides country-level regulatory expertise for drug development projects, supporting clients from pre-award through submission and approval, and acting as the regulatory subject matter expert for assigned projects.

Key responsibilities

• Deliver quality outputs at country and site level, following project requirements and country rules under project oversight.
• Maintain up-to-date knowledge of RA/EC processes, timelines and applicable regulations and guidelines, and identify relevant pre- and post-market requirements.
• Support business development and site selection with country-level regulatory advice, and keep project teams informed on country start-up timelines.
• Forecast submission and approval timelines, track milestones, analyse delays, propose mitigation plans and escalate risks.
• Prepare and submit Central EC, Local EC, RA applications and other regulatory approvals, and ongoing submissions for amendments, periodic notifications and safety reports.
• Interact directly with RAs and ECs, coordinate and submit query responses, and influence regulators through local CRO associations when needed.
• Act as the country regulatory SME point of contact throughout the life of assigned projects.
• Ensure documents are submitted to the Trial Master File in line with SOPs and customer requirements, and contribute to regulatory intelligence systems and Regulatory Impact Assessments.
• Develop or support local regulatory training materials, support the Procurement team with Ethics/IRB vendors, and improve quality of submissions and communications.
• Review SOPs and Work Instructions, ensure training compliance, keep accurate timesheets, and monitor workload, budgeted effort and project hours.