Regulatory and Start Up Specialist

📋 Description

• Delivery of site activation readiness for assigned sites
• Prepare Clinical Trial Applications and submission dossiers
• Interact with CA/EC and handle responses
• Provide updates to Start Up Lead, Regulatory Lead, PM
• Maintain project plans, trackers, and regulatory tools
• Develop/start-up plans, IMP release requirements, essential reviews

🎯 Requirements

• Bachelor in life sciences or RN or equivalent
• Regulatory/start-up experience in CRO/pharma/biotech
• Experience with CA/EC submissions and regulatory timelines
• Romanian/Hungarian/English language for Romania is preferred
• Strong communication and organizational skills
• Fluency in English; IT systems and MS Office proficiency

🎁 Benefits

• Remote work options for Hungary/ Romania region
• Equal opportunity employer
• Support for regulatory and site start-up career growth