Regulatory and Start Up Specialist (Clinical Research)

Location: Remote, Poland

Company

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

What you will do

• Manage site activation readiness for assigned Hungarian sites, ensuring timely and high-quality delivery while identifying and mitigating risks.
• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies.
• Interact with regulatory and ethics authorities, coordinate responses, and provide submission status updates to study leadership and project teams.
• Coordinate essential document collection, site review, IMP release requirements, informed consent and patient information materials, and document translations.
• Maintain project plans, trackers, regulatory intelligence tools, critical-path data, and audit-ready Trial Master File documentation.
• Collaborate with Clinical Operations, Feasibility, Project Management, Regulatory, Site Contracts, and CRAs on site start-up, budgets, contracts, and feasibility activities.

Requirements

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

Nice to have

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

Culture & Benefits

• Remote work arrangement based in Poland.
• Work within an integrated Clinical Research Organization focused on precision medicine, rare diseases, oncology, and clinical trial innovation.
• Cross-functional collaboration with regulatory, clinical operations, feasibility, project management, and site contract teams.
• Commitment to maintaining inspection readiness and compliance with international and local regulations, company SOPs, and ICH-GCP principles.