SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
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 site activation in Hungary and the Central European region. Your core responsibilities include:
• Preparing and submitting Clinical Trial Application Forms and regulatory dossiers (initial and amendments) to Competent Authorities, Ethics Committees, and local regulatory bodies according to local requirements and ICH-GCP principles
• Managing interactions with regulatory and ethics authorities, handling responses and providing regular updates to leadership and project teams
• Developing and maintaining project plans, trackers, and regulatory intelligence tools; ensuring Regulatory Leadership stays informed
• Preparing study-specific start-up plans, IMP release requirements, and essential document review criteria
• Coordinating with site Clinical Research Associates to ensure alignment and secure site activation
• Reviewing and managing collection of essential documents required for site activation and IMP release
• Customizing country and site-specific Patient Information Sheets and Informed Consent Forms
• Facilitating translation coordination for regulatory and study documents
• Maintaining communication across key functions (Feasibility, Clinical Operations, Project Management, Site Contracts) on project status and deliverables
• Acting as subject matter expert for site-level critical path data, including CA/EC/IRB timelines, site contracts, and budget negotiations
• Supporting budget negotiation and investigator contract execution under Site Contract Management direction
• Supporting feasibility assessments and site outreach activities
• Maintaining current knowledge of local clinical trial laws and regulations; distributing expertise across the organization
• Maintaining audit and inspection readiness; filing documents per Trial Master File plans
• Supporting pre-study site visits as needed
Requirements:
Minimum Required:
• Bachelor's degree in life sciences or related field (scientific or healthcare discipline), or Registered Nurse (RN) credential, 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 (essential for supporting Hungarian sites)
• Strong communication and organizational skills
• Proficiency 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 and 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
