Senior Country Regulatory Specialist

Syneos Health

. Perform country regulatory operations from study startup through project end .

Posted 10/15/2026full-timeRemote • MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in country regulatory operations, including ethics and regulatory submissions, while effectively managing timelines and budgets. Capable of training and mentoring junior specialists and ensuring compliance with local regulations and GxPs.

Highest-signal resume keywords

Clinical Trial Submission ProcessesRegulatory Authority InteractionGxP ComplianceTraining and MentoringProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ProcessRegulatory SubmissionsRegulatory Intelligence SystemsRegulatory Impact AssessmentsSOP DevelopmentEthics Committee SubmissionsProject Milestone TrackingMitigation PlanningGCP KnowledgeISO 14155 Understanding

Soft Skills

Organizational SkillsProblem-Solving SkillsPresentation SkillsCommunication SkillsTeam-Oriented Approach

Tools & Technologies

Microsoft Office SuiteWeb-Based SystemsEmailVoicemailInternet

Industry Keywords

Clinical ResearchPhases I-IVGVPIRB ManagementCountry Regulatory Expertise

About the role

Key responsibilities & impact

Perform country regulatory operations from study startup through project end
Provide expertise in country ethics and regulatory submissions within timelines, budgets, and quality standards
Serve as the main country-level contact with Regulatory Authorities and Ethics Committees under project leadership
Maintain regulatory country intelligence in regulatory intelligence systems
Interact with customers regarding Regulatory Authority and local regulatory requirements
Consult on pre-award regulatory submission strategy
Provide country-level regulatory expertise for business development presentations and site selection
Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks
Prepare and submit Central Ethics Committee, Local Ethics Committee, Regulatory Authority, hospital, amendment, notification, and safety submissions
Interact with Regulatory Authorities and Ethics Committees and coordinate query responses
Serve as country-level regulatory SME throughout assigned projects
Ensure relevant documents are submitted to the Trial Master File
Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change
Develop or support local country regulation training materials
Train and mentor junior Country Regulatory Specialists
Support Procurement in managing Ethics/IRB vendors when required
Provide input to SOPs and Work Instructions and drive continuous quality improvement
Review 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

Minimum of a BA or BS preferred
5-6 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
Strong presentation, documentation, influencing, and communication skills
Team-oriented approach
Knowledge and interpersonal skills necessary to train and mentor junior Country Regulatory Specialists
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
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
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate