Senior Global Clinical Trials Regulatory Lead

Syneos Health, Inc.; Bogotá; Hybrid; COP 120.000.000 - 200.000.000; Vollzeit

Zusammenfassung

Syneos Health is seeking a Principal Clinical Trial Regulatory Affairs professional with +4 years of experience in multi-country regulatory submissions. The role is based in Colombia and offers hybrid work in Colombia.

You will support customer-focused leadership and management of CTRA deliverables across projects, developing regulatory strategies and ensuring timely submissions. You will compile core packages, perform regulatory assessments, and maintain strategic relationships with customers

Qualifikationen

• Bachelor’s Degree, higher degree preferred.
• Experience with regulatory submissions and regulatory strategy.
• Strong collaboration and communication with cross-functional teams.

Aufgaben

• Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate issues in Site Activation pathway.
• Prepares and presents overall submission strategy and status at client meetings and communicates outcomes to project team.
• Review clinical trial core documents for regulatory compliance.
• Coordinate regulatory core submissions and track study-level packages.
• Maintain relationships with customers and ensure deliverables meet expectations.

Kenntnisse

Regulatory submissions

Regulatory strategy

Team leadership

Regulatory writing

Budget management

Ausbildung

Bachelor’s degree, higher degree preferred

Tools

CTIS

Jobbeschreibung

Syneos Health is seeking a Principal Clinical Trial Regulatory Affairs professional with +4 years of experience in multi-country regulatory submissions. The role is based in Colombia and offers hybrid work in Colombia.

You will support customer-focused leadership and management of CTRA deliverables across projects, developing regulatory strategies and ensuring timely submissions. You will compile core packages, perform regulatory assessments, and maintain strategic relationships with customers