Country Regulatory Specialist, Clinical Research

Syneos Health

. Perform assigned activities related to country regulatory operations under supervision .

Posted 10/15/2026full-timeRemote • BrazilMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in country regulatory operations, including clinical trial submission processes and compliance with applicable GxPs. Proven ability to manage regulatory submissions, maintain country intelligence, and provide strategic recommendations throughout the project lifecycle.

Highest-signal resume keywords

Regulatory SubmissionsClinical Trial ProcessesGxP ComplianceRegulatory Intelligence SystemsProblem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsClinical Trial ProcessesGxP ComplianceRegulatory Intelligence SystemsRegulatory Impact AssessmentsSubmission StrategyProject ManagementSOP ComplianceDocument PreparationCountry-Specific Regulations

Soft Skills

Organizational SkillsProblem-Solving SkillsCommunication SkillsTeam-Oriented ApproachAbility to Meet Deadlines

Tools & Technologies

Microsoft Office SuiteWeb-Based SystemsTrial Master File

Industry Keywords

Clinical ResearchEthics CommitteesRegulatory AuthoritiesPhases I-IVICH GCP

About the role

Key responsibilities & impact

Perform assigned activities related to country regulatory operations under supervision
Provide delivery and expertise in country ethics and regulatory submissions from startup through project end
Serve as the main country-level contact with Regulatory Authorities and Central/Regional Ethics Committees under project leadership direction
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 subject matter expertise for business development presentations and site selection
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 Central EC, Local EC, Regulatory Authority, hospital, amendment, periodic notification, safety notification, and other local submissions
Interact with Regulatory Authorities and Ethics Committees, coordinate query responses, and identify solutions to issues
Serve as country-level regulatory SME throughout assigned projects
Submit relevant documents to the Trial Master File in compliance with SOPs and customer requirements
Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change
Develop or support local country regulation training materials
Support Procurement in managing Ethics/IRB vendors when required
Ensure continuous quality improvement for country-level submissions and communications
Comply with SOPs and Work Instructions, maintain training compliance and accurate 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
Ideally, experience in a regulatory area
Detailed understanding of clinical trial processes across Phases I-IV and ICH GCP
Detailed understanding of country-specific and local clinical trial submission processes and 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 written and spoken communication skills
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
English advanced

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Remote work arrangement (100% remote in Brazil)