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Precision for Medicine is a Clinical Research Organization specializing in precision medicine, combining novel clinical trial designs, operational expertise, biomarker analytics, and focus on rare diseases and oncology.
You will serve as a Regulatory and Start-Up Specialist supporting clinical trial activation in Hungary. Your core responsibilities include:
• Deliver site activation readiness across assigned Hungarian sites and countries, managing timelines, quality, and risk mitigation
• Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments) for Competent Authorities, Ethics Committees, and local regulatory bodies per local requirements and ICH-GCP principles
• Interact with regulatory and ethics bodies, handle their responses, and provide regular updates to leadership and project teams
• Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership informed
• Develop study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with site Clinical Research Associates to ensure aligned communication and secure site reviews
• Manage collection of essential documents required for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Facilitate translation coordination for regulatory documents
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams on project status and deliverables
• Act as subject matter expert for site-level critical path data (CA/EC/IRB timelines, site contracts, budget requirements)
• Support negotiation of study budgets and investigator contracts under Site Contract Management direction
• Support feasibility team in site outreach and investigator interest assessment
• Maintain current knowledge of local clinical trial laws and regulations; distribute knowledge across the organization
• Maintain audit/inspection readiness and file documents per TMF plans
• May support Pre-Study Site Visits
REQUIREMENTS:
Minimum Required:
• Bachelor's degree in life sciences or related field (scientific or healthcare discipline), or Registered Nurse (RN), or equivalent combination of education, training, and experience
• Pharmacy qualification or pharmacist work experience highly beneficial
• Demonstrated experience as a Regulatory or Start-Up Specialist (or comparable role) in a CRO, pharmaceutical, or biotech industry, or equivalent relevant experience and demonstrated competencies
• Fluency in Hungarian language (required to support Hungarian sites)
Other Required:
• Strong communication and organizational skills
• Experience with computerized information systems, electronic spreadsheets, word processing, and email
• Fluency in English
Preferred:
• Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions)
• Experience with milestone tracking tools/systems
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or Master's in Regulatory Science
