Country Regulatory Specialist – NAMER Submission Expertise

Syneos Health

. Provide quality deliverables at the country and site level, following project requirements and applicable country rules .

Posted 10/16/2026full-timeMorrisville • North Carolina • United StatesMid-LevelSenior💰 $67,700 - $115,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs and ethics committee processes, ensuring compliance with country-specific regulations and clinical trial requirements. Proven ability to manage project timelines, submissions, and stakeholder communications effectively.

Highest-signal resume keywords

Regulatory Affairs ExpertiseClinical Trial Process KnowledgeGxP Compliance ExperienceStrong Organizational SkillsEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission ProcessesClinical Trial Phases I-IVRegulatory Intelligence SystemsRegulatory Impact AssessmentsProject ManagementSOP ComplianceAmendment PreparationMilestone TrackingRisk Mitigation PlanningEthics Committee Interaction

Soft Skills

Problem-Solving SkillsTeam-Oriented ApproachAbility to Meet DeadlinesPresentation SkillsInfluencing Skills

Tools & Technologies

Microsoft Office SuiteWeb-Based SystemsEmailInternet

Industry Keywords

Clinical ResearchICH GCPGVPISO 14155Trial Master FileCountry-Specific RegulationsEthics/IRB Management

About the role

Key responsibilities & impact

Provide quality deliverables at the country and site level, following project requirements and applicable country rules
Maintain expert knowledge of RA/EC processes, requirements, timelines, regulations, laws, and guidance documents
Provide country-level regulatory subject matter expertise during business development and site selection
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 Central EC, Local EC, RA, regulatory authority, and hospital approval applications
Prepare ongoing amendments, periodic notifications, safety notifications, and other required submissions
Interact directly with regulatory authorities and ethics committees and coordinate query responses
Serve as 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 complete or contribute to Regulatory Impact Assessments
Develop or support local country regulation training materials
Support management of Ethics/IRB vendors with the Syneos Health Procurement team
Ensure continuous improvement of country-level quality
Review and comply with SOPs and Work Instructions, maintain training compliance, and accurately report timesheets
Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies

Requirements

What you’ll need

Minimum of a BA or BS preferred
3-4 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience
Detailed understanding of clinical trial process across Phases I-IV and ICH GCP
Detailed understanding of clinical trial submission processes per country and local regulations
Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
Strong organizational and problem-solving skills
Proven ability to meet deadlines with high quality
Strong presentation, documentation, influencing, and communication skills, written and spoken
Team-oriented approach
Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet
Ability to manage competing priorities in a dynamic fast-paced environment
Demonstrated ability to work independently and as part of a team

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Inclusive culture
Company car or car allowance
Medical, Dental and Vision health benefits
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO)
Sick time
Reasonable accommodations, when appropriate