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.
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, Local clinical trial law knowledge, Document translation coordination, Project tracking
Preferred skills
Pharmacy qualification, Advanced degree in medical/life sciences, RAC certification, Masters in Regulatory Science, Milestone tracking tools experience
Technologies
Electronic spreadsheets, Word processing, Computerized information systems, TMF (Trial Master File)
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 feasibility and site outreach; Maintain audit/inspection readiness.
Seniority
Individual Contributor
