Country Regulatory Specialist

About the role

Syneos Health is hiring a Country Regulatory Specialist in Tokyo, working in a hybrid setting. The specialist provides country-level regulatory expertise for clinical trials, supporting project teams from the pre-award stage through submission and approval, and acting as the regulatory SME point of contact for assigned projects.

Key responsibilities

• Deliver quality outputs at country and site level, following project requirements and country rules under project oversight from the PL/RL/SAM.
• Maintain expert knowledge of RA/EC processes, requirements and timelines, and of applicable regulations and guidelines.
• Support business development and site-selection presentations with country-level regulatory insight.
• Track submission and approval timelines, monitor milestones, analyse delays, propose mitigation plans and escalate risks.
• Prepare and submit Central EC, Local EC, RA applications and other submissions to authorities and hospitals, including amendments, periodic notifications and safety notifications.
• Interact directly with RAs and ECs, coordinate and submit query responses, and influence regulators through local CRO associations when needed.
• Ensure documents are submitted to the Trial Master File (TMF) in line with SOPs and customer requirements.
• Maintain regulatory intelligence, contribute to Regulatory Impact Assessments and implement operational actions as regulations change.
• Develop or support local regulatory training materials and support the Procurement team in managing Ethics/IRB vendors.
• Review SOPs and Work Instructions, ensure training compliance, and report accurate timesheets.
• Monitor workload, budgeted effort and project hours, escalating discrepancies promptly.

Required profile

• Expert knowledge of RA/EC processes, requirements and timelines.
• Ability to forecast submission and approval timelines and manage regulatory queries.
• Experience and understanding of Japanese regulatory requirements.

What we offer

• Career development, progression and technical and therapeutic area training.
• Supportive line management, peer recognition and a total rewards program.
• An inclusive culture centred on the purpose "Driven to Deliver".