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Syneos Health

Country Regulatory Specialist

Syneos Health

. Provide quality deliverables at 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, ensuring compliance with applicable regulations and guidelines. Capable of preparing and submitting various regulatory submissions while maintaining country-specific regulatory intelligence.

Highest-signal resume keywords
Expert Knowledge Of RA/EC ProcessesCountry-Level Regulatory Subject Matter ExpertiseAbility To Prepare And Submit Regulatory ApplicationsAbility To Interact With Regulatory AuthoritiesAbility To Maintain Regulatory Intelligence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory Submission PreparationEthics Committee SubmissionRegulatory Authority InteractionRegulatory Impact AssessmentsCompliance With SOPsMonitoring Workload And BudgetProject Timeline ForecastingMitigation PlanningQuality ImprovementTraining Material Development
Soft Skills
Strategic RecommendationsCommunication With StakeholdersProblem-SolvingCollaboration With Procurement Team
Tools & Technologies
Regulatory Intelligence SystemsTrial Master File Management
Industry Keywords
Country-Specific RegulationsPre-Market RequirementsPost-Market RequirementsEthics CommitteeRegulatory Guidelines

About the role

Key responsibilities & impact
  • Provide quality deliverables at country and site level in accordance with project requirements and applicable country rules
  • Provide country-level regulatory subject matter expertise during pre-award business development presentations
  • Support site selection by advising on appropriate sites based on project requirements and timelines
  • Maintain intelligence on country-specific startup 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, hospital approval, amendment, periodic notification, and safety submissions
  • Interact with regulatory authorities and ethics committees and coordinate responses to queries
  • 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 implement operational actions as regulations change
  • Develop or support local country regulation training materials
  • Support the Procurement team in managing Ethics/IRB vendors when required
  • Ensure continuous quality improvement for country-level submissions and communications
  • Monitor workload, budgeted effort, and project hours and 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
  • Ability to prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications
  • Ability to prepare ongoing amendments, periodic notifications, safety notifications, and other regulatory submissions
  • Ability to interact directly with regulatory authorities and ethics committees and respond to queries
  • Ability to maintain regulatory intelligence and complete/contribute to Regulatory Impact Assessments
  • Ability to develop or support local country regulation training materials
  • Ability to comply with SOPs, Work Instructions, training requirements, and timesheet reporting
  • Ability to monitor workload, scope, budgeted effort, and project hours

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