Country Study Start-Up Specialist I/ Ii

What You'll DoSupport of Regulatory Affairs Study Start-Up (RASSU) departmentInforms the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country levelReview/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central and Local) and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements (e.G. via portal up…