Regulatory and Start Up Specialist (Clinical Research)

Location: Remote, Slovakia

Company

hirify.global is a Clinical Research Organization supporting precision medicine studies through clinical trial operations, medical expertise, biomarker and data analytics solutions, and work across rare diseases, oncology, and other therapeutic areas.

What you will do

• Prepare Clinical Trial Applications and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
• Coordinate responses and ongoing communication with Competent Authorities and Ethics Committees.
• Drive site activation readiness by managing essential documents, IMP release requirements, regulatory timelines, contracts, budgets, and country-specific critical paths.
• Customize Patient Information Sheets and Informed Consent Forms and coordinate document translations.
• Maintain project plans, trackers, regulatory intelligence tools, and audit-ready documentation in the TMF.
• Collaborate with Regulatory, Clinical Operations, Project Management, Feasibility, Site Contracts, and site CRA functions, including support for feasibility and pre-study site visits.

Requirements

• Bachelor’s degree in life sciences or a related field, or Registered Nurse qualification, or an equivalent combination of education, training, and experience.
• Experience as a Regulatory or Start Up Specialist, or in a comparable role within a CRO, pharmaceutical, or biotechnology organization.
• Fluent Hungarian required to support Hungarian clinical sites.
• Fluent English required.
• Strong communication, organizational, prioritization, and deadline-management skills.
• Experience with computerized information systems, spreadsheets, word processing, email, and milestone tracking tools.

Nice to have

• Pharmacy qualification or experience as a Pharmacist.
• Experience with feasibility, contract negotiations, and Competent Authority, Ethics Committee, or IRB submissions.
• Advanced medical or life sciences degree, RAC certification, or a Master’s in Regulatory Science.

Culture & Benefits

• Remote work arrangement from Slovakia.
• Work within an integrated Clinical Research Organization focused on precision medicine, rare diseases, oncology, and other therapeutic areas.
• Cross-functional collaboration across regulatory, clinical, operational, feasibility, project management, and site contract functions.
• Employment requires legal authorization to work in the country of employment without employer sponsorship.