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 site selection and submission, 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 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 contribute to regulatory intelligence systems and Regulatory Impact Assessments.
• Ensure documents are submitted to the Trial Master File in line with SOPs and customer requirements.
• Develop or support local regulatory training materials and support the Procurement team with Ethics/IRB vendors when needed.
• Review SOPs and Work Instructions, ensure training compliance, and report accurate timesheets.

Required profile

• Expert knowledge of RA/EC processes and timelines.
• Ability to act as the country regulatory SME for projects and to liaise with regulatory authorities.

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.