Regulatory and Start Up Specialist (Clinical Research)

Location: Remote, Romania

Company

hirify.global is a clinical research organization supporting precision medicine through clinical trial operations, medical expertise, biomarker solutions, and data analytics, with a focus on rare diseases and oncology.

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 regulatory and ethics authorities.
• Manage project plans, trackers, regulatory intelligence tools, and site activation critical-path data.
• Coordinate essential document collection, review, translations, informed consent materials, and IMP release requirements.
• Collaborate with Clinical Operations, Project Management, Feasibility, Site Contracts, CRAs, and regulatory teams to deliver site activation milestones.
• Maintain audit and inspection readiness and support feasibility activities, budget negotiations, investigator contracts, and pre-study site visits.

Requirements

• Bachelor’s degree in life sciences or a related scientific or healthcare field, or RN qualification or equivalent experience.
• Demonstrated experience as a Regulatory or Start Up Specialist, or in a comparable CRO, pharmaceutical, or biotechnology role.
• Romanian, Hungarian, and English are required for candidates applying from Romania.
• 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 professional 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 for Romania-based employees.
• Work within an integrated clinical research organization focused on precision medicine, rare diseases, and oncology.
• Cross-functional collaboration across regulatory, clinical operations, feasibility, project management, and site contracts teams.
• Focus on regulatory compliance, audit readiness, quality, and timely delivery.