Regulatory and Start Up Specialist - Fluent in Hungarian
Core
Regulatory and Start Up Specialist ensuring timely site activation, clinical trial application submissions, and compliance with local regulations for Hungarian sites.
Role type
Regulatory and Start Up Specialist
Builds
Clinical trial authorizations and site activation readiness
Domain
Clinical Research / Precision Medicine
Required skills
Regulatory submission preparation, Competent Authority interaction, Site activation management, Contract negotiation support, Feasibility assessment, Local clinical trial law knowledge, Document translation coordination, TMF maintenance
Preferred skills
Pharmacy qualification, Advanced degree in medical/life sciences, RAC certification, Masters in Regulatory Science, Milestone tracking tools experience
Technologies
Computerized information systems, Electronic spreadsheets, Word processing, Electronic mail
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
Individual Contributor
