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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 and assigned countries. Your core responsibilities include:
• Deliver site activation readiness on time and with quality, managing risks across assigned country/sites
• Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments) for Competent Authorities, Ethics Committees, and local bodies per local requirements and timelines
• Interact with regulatory and ethics bodies, handling submissions and responses
• Provide regular updates on CA/EC submissions to Start-Up Lead, Regulatory Lead, and Project Managers
• Maintain project plans, trackers, and regulatory intelligence tools
• Develop study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with site CRAs to ensure alignment and secure site review of essential documents for activation/IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Manage translation coordination for regulatory documents
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as SME for site-level critical path data (CA/EC/IRB timelines, contracts, budget requirements)
• Support budget negotiation and investigator contract execution 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 expertise across PFM
• Maintain audit/inspection readiness and file documents per TMF plan
• 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 Regulatory or Start-Up specialist (or comparable role) in CRO, pharmaceutical, or biotech industry, or equivalent relevant experience/competencies
• Fluency in Hungarian language (position supports 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 Masters in Regulatory Science
