Job Overview

• Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements.
• Complete submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues.
• 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 appropriate systems are updated accurately and compliantly, ensuring others follow established processes.
• Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
• Mentor and coach other Site Readiness and Regulatory Operations team members.

In-Country specific tasks (Integral)

• Serve as primary contact for investigative sites and ensure documents required a...