Regulatory and Start Up Specialist - Fluent in Hungarian
Core
Regulatory and Start Up Specialist ensuring site activation readiness, preparing Clinical Trial Applications, and managing interactions with Competent Authorities and Ethics Committees for clinical trials in Hungary.
Role type
Regulatory and Start Up Specialist
Builds
Clinical trial authorizations and site activations
Domain
Clinical Research / Precision Medicine / Oncology
Required skills
Regulatory submission preparation, Competent Authority interaction, Ethics Committee management, Site activation planning, Contract negotiation support, Translation coordination, Local clinical trial law knowledge, Project tracking
Preferred skills
Pharmacy qualification, Milestone tracking tools, Feasibility assessment, Site outreach
Technologies
Electronic spreadsheets, Word processing, Computerized information systems, TMF management tools
Responsibilities
Prepare Clinical Trial Application Forms and submission dossiers, Interact with Competent Authorities and Ethics Committees, Maintain project plans and regulatory intelligence tools, Customize Patient Information Sheets and Informed Consent Forms, Facilitate document translations, Support site contract negotiations, Maintain audit/inspection readiness
Seniority
Mid-level, hands-on IC
