FSP Country Approval Specialist

Prepare, review and coordinate local regulatory submissions (MoH, EC, and other national/local applications) in alignment with global strategy; provide local regulatory strategy advice to internal clients; coordinate project-specific SIA services; may interact with investigators for submission-related activities; serve as key country-level contact for submission-related activities; coordinate with internal departments to align site start-up activities with submission timelines and site activation; support timely cycle times for studies; assist with regulatory compliance review packages and with Patient Information Sheet/Informed Consent documents; assist with grant budgets and payment schedules; maintain trial status information in tracking databases; ensure local country study files and filing processes meet SOPs; maintain knowledge of applicable SOPs and regulatory guidelines; working conditions may include office/lab/clinical environments with exposure to biological materials; strong written and verbal communication, interpersonal, organizational and planning skills; ability to work in a team or independently under direction; English proficiency; basic medical terminology knowledge.