Site Readiness And Reg Specialist Ii (Xico)

Job Overview: Summary of ResponsibilitiesMaintain awareness of regulatory legislation, guidance, and practice in the assigned countries.Compile and prepare routine submission 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 escape study issues appropriately and in a timely fashion.Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).
In Country specific tasks (General)Serve as primar...