Regulatory and Site Start Up Specialist

📋 Description

• Preparation of Clinical Trial Application Forms and submission dossier (initial and
• Interaction with CA/EC for study purposes and handling responses to the CA/EC
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead
• Maintenance of project plans, project trackers and regulatory intelligence tools
• Preparation/Support of study specific start-up plans, IMP release requirements and essential
• Partner with assigned site CRA to ensure alignment in communication and secure site collaboration

🎯 Requirements

• Bachelor's degree in life sciences or related field (ideally scientific or healthcare discipline)
• 1 year or more as a Regulatory or Site Start Up Specialist (or comparable role) in CRO or
• Strong communication and organizational skills
• Experience using computerized information systems, electronic spreadsheets, word processing and
• Fluency in English and local language of country where position based
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions)