Clinical Trial Regulatory Specialist

Syneos Health

. Perform assigned activities within the CTRA team under supervision .

Posted 10/22/2026full-timeBuenos Aires • ArgentinaEntry LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submissions and compliance with applicable GxPs, including GVP and GCP, while maintaining strong client relationships and effective communication skills.

Highest-signal resume keywords

Regulatory Core SubmissionsGxP ComplianceAdvanced English ProficiencyMicrosoft Office SuiteQuality-Control Reviews

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsQuality-Control ReviewsDocument TrackingTechnical DocumentationCompliance Standards

Soft Skills

Interpersonal SkillsPresentation SkillsTeam-Oriented ApproachInfluencing SkillsDocumentation Skills

Tools & Technologies

Microsoft Office SuiteWeb-Based SystemsEmailVoicemailInternet

Industry Keywords

GxPGVPGCPISO 14155Healthcare Products

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform assigned activities within the CTRA team under supervision
Review and finalize essential core documents required for site initiation, regulatory and core submissions, from site startup through study end
Prepare technical components of regulatory core submissions, such as EU Clinical Trial Regulation Part I and/or II
Support agency interactions
Compile and perform regulatory core submissions under supervision
Conduct quality-control reviews of documents and send them for review
Track documents through final submission or delivery to the client
Attend client meetings as needed and build client relationships in support of projects and deliverables
Identify and report process and risk areas
Maintain compliance and accuracy with relevant quality standards
Meet utilization targets and departmental goals
Maintain current knowledge of applicable regulations and guidelines
Identify relevant laws, regulations, and guidance documents covering pre- and post-market requirements for healthcare products
Perform activities in compliance with corporate and divisional policies, standard operating procedures, and operating guidelines
Perform other duties assigned by management

Requirements

What you’ll need

Minimum of a BA or BS preferred
Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
Advanced English required
Excellent presentation, documentation, influencing, and interpersonal skills (written and spoken)
Team-oriented approach
Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, email, and Internet
Ability to travel as required, approximately 10%
Ability to work in a hybrid arrangement in Buenos Aires, Argentina, two times per week in the office

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