Senior Regulatory and Start Up Specialist (Argentina)

📋 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
• Preparation/Support the development of study-specific start-up plans, IMP release requirements and

🎯 Requirements

• Bachelor's degree in life sciences or related field (or Registered Nurse qualification)
• 3.5+ years as a Regulatory or SU specialist in CRO or pharma/biotech industry or equivalent
• Ability to communicate proficiently in English (professional level)
• Excellent organizational and communication skills
• Experience with computer systems, spreadsheets, word processing, email required
• Fluency in English and local language (Spanish) where position based