Principal RASSU Specialist

** Please submit your application in English ** What You'll Do:Support of Regulatory Affairs Study Start-Up (RASSU) department: • Assist/Advise project teams on all regulatory requirements for clinical studies • Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings • Review and adapt study specific documents according each country and sites requirements • Perform / oversee IRB/IEC/ and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements • Receive and process study documentation from sites, check content and quality as well as completeness • Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review • Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements and /or perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements • Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy • Preparation and/or quality check and filing of site adapted ICF according to local requirements • Prepare or/and QC Clinical Trial Application forms (e.