Site Readiness and Regulatory Specialist Ii (Santiago)

Job Overview

Summary of Responsibilities

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
• Compile and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
• Perform a review of final submission documents as applicable.
• Ensure that all assigned start‑up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.
• Prevent and escalat?? study issues appropriately and in a timely fashion.
• Perform other duties as assigned by management depending upon country and situational requirements with proper sup...