Site Readiness And Reg Specialist Ii

**Job Overview**:**Summary of Responsibilities**:- Maintain 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 escalate 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 Coun...