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Syneos Health

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

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Demonstrates expert knowledge of Regulatory Affairs and Ethics Committee processes, with the ability to forecast submission timelines and manage local regulatory submissions effectively. Maintains compliance with SOPs and contributes to continuous quality improvement at the country level.

Highest-signal resume keywords
Expert Knowledge Of RA/EC ProcessesCountry-Level Regulatory Subject Matter ExpertiseAbility To Prepare And Submit Regulatory ApplicationsAbility To Forecast Submission And Approval TimelinesAbility To Interact With Regulatory Authorities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory SubmissionsSubmission Timeline ForecastingRegulatory Intelligence MaintenanceRegulatory Impact AssessmentsEthics Committee ApplicationsLocal Regulatory Authority ApplicationsOngoing Amendments PreparationSafety Notifications PreparationCompliance With SOPsAccurate Timesheet Reporting
Soft Skills
Problem-SolvingCommunicationCollaborationAnalytical ThinkingAttention To Detail
Tools & Technologies
Regulatory Intelligence SystemsTrial Master File Management
Industry Keywords
Country-Specific Start-Up TimelinesPre-Market RequirementsPost-Market RequirementsEthics/IRB Vendor ManagementQuality Improvement

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 presentations
  • Support site selection by providing country-level regulatory expertise
  • Maintain intelligence on country-specific start-up timelines and provide strategic recommendations
  • Forecast submission and approval timelines, track milestone progress, analyze delays, propose mitigation plans, and escalate risks
  • Prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval submissions
  • Prepare ongoing amendments, periodic notifications, safety notifications, and other local regulatory submissions
  • Interact directly with regulatory authorities and Ethics Committees, identify solutions, and coordinate 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 intelligence in regulatory intelligence systems and contribute to regulatory impact assessments and operational actions
  • Develop or support local country regulation training materials
  • Support the Procurement team in managing Ethics/IRB vendors when required
  • Ensure continuous quality improvement at the country level
  • Review and comply with SOPs and Work Instructions, maintain training compliance, and report timesheets accurately
  • 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 laws, regulations, and guidance documents covering pre- and/or post-market requirements
  • Country-level regulatory subject matter expertise
  • Knowledge of country-specific start-up timelines
  • Ability to forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks
  • Ability to prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions
  • Ability to prepare ongoing amendments, periodic notifications, safety notifications, and other regulatory submissions as required by local regulations
  • Ability to interact directly with regulatory authorities and Ethics Committees, and coordinate query responses
  • Ability to maintain regulatory intelligence and complete/contribute to Regulatory Impact Assessments
  • Ability to develop or support local country regulation training materials
  • Ability to manage Ethics/IRB vendors when required
  • Ability to comply with SOPs, Work Instructions, training requirements, and accurate 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, under the Americans with Disabilities Act