Regulatory Start-Up Specialist (Remote – Hungary)

Openkrill; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Precision Medicine Group is seeking a Start Up Specialist to join a growing team. The role focuses on preparing regulatory submissions, interacting with authorities and ethics committees, and coordinating site activation for Hungary and surrounding regions.

Candidates with Hungarian fluency and CRO/start-up experience are preferred. We welcome applicants at all levels with life sciences backgrounds and strong organizational skills, capable of working across regulatory, feasibility, and clinical

Qualifications

• Bachelor’s degree in life sciences or RN or equivalent combination of education, training, and experience.
• Pharmacy qualification/experience would be highly beneficial.
• Regulatory or Start Up experience in CRO or pharmaceutical/biotech industry or equivalent.

Responsibilities

• Prepare Clinical Trial Applications and submission dossiers for CA/EC and local bodies according to local requirements and timelines.
• Coordinate with CA/EC and provide updates to Start Up Lead, Regulatory Lead, and Project Manager.
• Maintain project plans, trackers, and regulatory intelligence tools related to start-up responsibilities.
• Support start-up plans, IMP release requirements, and essential document review criteria.
• Collaborate with site CRA to ensure alignment and secure site activation.
• Review and manage collection of essential documents for site activation/IMP release.
• Customize patient information sheets and informed consent forms for countries/sites.
• Coordinate translations and liaise with other functions on project status and deliverables.
• Maintain knowledge of local clinical trial laws and ensure compliance; support feasibility and budget negotiations as needed.

Job description

Precision Medicine Group is seeking a Start Up Specialist to join a growing team. The role focuses on preparing regulatory submissions, interacting with authorities and ethics committees, and coordinating site activation for Hungary and surrounding regions.

Candidates with Hungarian fluency and CRO/start-up experience are preferred. We welcome applicants at all levels with life sciences backgrounds and strong organizational skills, capable of working across regulatory, feasibility, and clinical