Principal Regulatory Trials Lead Submissions (Hybrid)

Syneos Health, Inc.; Colombia; Hybrid; COP 254,404,000 - 381,607,000; Full time

Job summary

Syneos Health, Inc. in Colombia is seeking a Principal Clinical Trial Regulatory Affairs professional with 4+ years of experience across multiple countries to lead regulatory submissions and CTRA deliverables in a hybrid Colombia setting.

You will develop strategic relationships with customers, coordinate submissions, and collaborate with cross-functional teams to drive timelines and regulatory success across trials.

Responsibilities

• Supports the customer-focused leadership and management of CTRA deliverables within the assigned projects.
• Contributes to the technical and operational aspects of the CTRA deliverables.
• Develops and maintains strategic relationships with customers.
• Compiles core packages, completes project regulatory assessments, submission forms and uploads documents to CTIS as required and reports progress including plans to address risks/gaps.
• Collaborates as Regulatory SME with major functional area leads to identify issues for Site Activation.
• Prepares and presents overall submission strategy and status at client meetings.
• Reviews core trial documents for regulatory compliance and coordinates regulatory submissions.
• Coordinates regulatory core submissions (e.g., EU CTR Part I) and tracks study-level submission packages.

Tools

CTIS

Job description

Syneos Health, Inc. in Colombia is seeking a Principal Clinical Trial Regulatory Affairs professional with 4+ years of experience across multiple countries to lead regulatory submissions and CTRA deliverables in a hybrid Colombia setting.

You will develop strategic relationships with customers, coordinate submissions, and collaborate with cross-functional teams to drive timelines and regulatory success across trials.