Country Regulatory Specialist

Syneos Health

. Provide quality deliverables at the country and site level in accordance with project requirements and applicable country rules .

Posted 11/9/2026full-timeTokyo • JapanMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expert knowledge of Regulatory Affairs and Ethics Committee processes, with the ability to prepare and submit various regulatory submissions and maintain compliance with applicable regulations. Proven capability in forecasting timelines, managing vendor relationships, and ensuring quality deliverables in accordance with project requirements.

Highest-signal resume keywords

Expert Knowledge Of RA/EC ProcessesCountry-Level Regulatory Subject Matter ExpertiseAbility To Prepare And Submit Regulatory SubmissionsAbility To Interact With Regulatory AuthoritiesCompliance With SOPs And Work Instructions

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Submission PreparationForecasting Submission TimelinesRegulatory Intelligence MaintenanceRegulatory Impact AssessmentsEthics Committee InteractionAmendments And Notifications PreparationQuery Response CoordinationVendor ManagementTraining Material DevelopmentCompliance Reporting

Soft Skills

Strategic RecommendationsQuality ImprovementProblem-SolvingCommunication

Tools & Technologies

Trial Master File ManagementSOP Compliance Tools

Industry Keywords

Regulatory AffairsEthics CommitteePre-Market RegulationsPost-Market RegulationsCountry-Specific Regulations

About the role

Key responsibilities & impact

Provide quality deliverables at the country and site level in accordance with project requirements and applicable country rules
Provide country-level regulatory SME support during pre-award business development
Support site selection based on project-specific requirements and timelines
Maintain intelligence on country-specific start-up timelines and provide strategic recommendations
Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks
Prepare and submit ethics committee, regulatory authority, and hospital approval applications
Prepare ongoing amendments, periodic notifications, safety notifications, and other required submissions
Interact with regulatory authorities and ethics committees and resolve issues
Coordinate, contribute to, and submit regulatory and ethics committee query responses
Serve as the country-level regulatory SME point of contact throughout assigned projects
Ensure relevant documents are submitted to the Trial Master File in compliance with SOPs and customer requirements
Maintain country regulatory intelligence and contribute to regulatory impact assessments and operational actions
Develop or support local country regulation training materials
Support the Syneos Health Procurement team in managing Ethics/IRB vendors when required
Ensure continuous quality improvement in country-level submissions and communications
Review and comply with SOPs and Work Instructions, maintain training compliance, and report accurate timesheets
Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies

Requirements

What you’ll need

Expert knowledge of RA/EC processes, requirements, and timelines
Current knowledge of applicable regulations and guidelines
Knowledge of relevant pre- and/or post-market laws, regulations, and guidance documents
Country-level regulatory subject matter expertise
Ability to forecast submission and approval timelines
Ability to prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval submissions
Ability to prepare ongoing amendments, periodic notifications, safety notifications, and other regulatory submissions
Ability to interact directly with regulatory authorities and ethics committees
Ability to coordinate and submit RA/EC query responses
Ability to maintain regulatory intelligence and complete Regulatory Impact Assessments
Ability to develop or support local country regulation training materials
Ability to manage Ethics/IRB vendors when required
Compliance with SOPs, Work Instructions, training, and timesheet reporting
Ability to monitor workload, scope, budgeted effort, and project hours
Equivalent experience, skills, and/or education will also be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate