Specialist Study Start Up & Regulatory Affairs

📋 Description Responsible for completing SSU and regulatory deliverables per SSU & RA plan. Liaise with SSU/regulatory team, authorities, vendors, sites for planning, organizing and executing Manage low-complexity study start-up activities under senior guidance. Prepare regulatory information for submissions to national authorities and ECs/IRBs. Track essential documents for Study Start-Up; ensure accuracy and completeness. Draft, negotiate, and execute clinical site agreements and amendments per timelines. 🎯 Requirements Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent. Experience in pharmaceutical/CRO industry. Strong knowledge of ICH GCP and national regulations for relevant territories. Good written and verbal communication; English proficiency. 🎁 Benefits