Regulatory and Site Start Up Specialist

📋 Description

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier
• 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 as it pertains to
• Preparation/Support the development of study specific start-up plans, IMP release requirements and

🎯 Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and
• Fluency in English.