Global Regulatory Lead — Clinical Trials & Submissions

Syneos Health, Inc.; Buenos Aires; Hybrid; ARS 1,200,000 - 2,400,000; Full time

Job summary

Syneos Health, Inc. is seeking a Senior Clinical Trial Regulatory Advisor in Argentina with experience in submissions across multiple countries and lifecycle regulatory management.

The role collaborates with global teams to drive regulatory success and ensures compliant delivery of core clinical trial materials. The position involves coordinating submissions, maintaining regulatory strategy, and engaging with customers to align on project plans and timelines.

Responsibilities

• Responsible and accountable for the customer-focused leadership and management of CTRA deliverables within a country, region or globally, within start-up, site activation and throughout the study life cycle.
• Contributes to the technical and operational aspects of the CTRA deliverables of the assigned projects.
• Compiles core packages, completes project regulatory assessments, submission forms and uploads documents to CTIS and reports progress including plans to address risks/gaps to the project team, PM, Site Activation Management and Sponsor.
• Collaborates with functional area leads to identify and evaluate issues pertaining to the Site Activation pathway.
• Ensures all project deliverables meet expectations, providing projections, reports and updates, and ongoing risk assessments.
• Develops and maintains strategic relationships with customers and assess client needs.
• Defines strategy with project leadership to execute milestones; presents overall Regulatory strategy at client meetings.
• Prepares core clinical trial application dossier for amendments and lifecycle maintenance; oversees country-specific applications.
• Identifies gaps in the evidence base.

Job description

Syneos Health, Inc. is seeking a Senior Clinical Trial Regulatory Advisor in Argentina with experience in submissions across multiple countries and lifecycle regulatory management.

The role collaborates with global teams to drive regulatory success and ensures compliant delivery of core clinical trial materials. The position involves coordinating submissions, maintaining regulatory strategy, and engaging with customers to align on project plans and timelines.