Regulatory And Start Up Specialist (Hungarian)

Location: Remote, Serbia

Company

hirify.global is a clinical research organization supporting precision medicine 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

• Coordinate site activation readiness for assigned Hungarian sites, ensuring timely and high-quality delivery while identifying and mitigating risks.
• Prepare clinical trial applications and submission dossiers for competent authorities, ethics committees, and other local bodies.
• Interact with competent authorities and ethics committees, manage responses, and provide submission updates to regulatory and project leadership.
• Coordinate essential document collection, site document review, IMP release requirements, patient information sheets, informed consent forms, and translations.
• Maintain project plans, trackers, regulatory intelligence tools, site-level critical paths, and audit-ready trial documentation.
• Collaborate with clinical operations, feasibility, project management, site contracts, CRAs, and regulatory teams on site activation, budgets, contracts, and study deliverables.

Requirements

• Bachelor’s degree in life sciences or a related field, or registered nurse qualification, or an equivalent combination of education, training, and experience.
• Relevant experience as a regulatory or start-up specialist in a CRO, pharmaceutical, or biotechnology company, or comparable experience.
• Fluent Hungarian is required to support Hungarian sites.
• Fluent English is 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 degree in regulatory science.

Culture & Benefits

• Remote work arrangement from Serbia.
• Work within an integrated clinical research organization focused on precision medicine, rare diseases, oncology, and other therapeutic areas.
• Cross-functional collaboration across regulatory, clinical operations, feasibility, project management, and site contracts teams.