Regulatory and Start Up Specialist (Portuguese speaker)

Added
13 hours ago
Type
Full time
Salary
Salary not provided

Related skills

negotiation english portuguese clinical trials regulatory submissions

📋 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

  • Minimum Required:
  • 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.
  • Demonstrated experience in contracts and budgeting negotiation experience, on top of experience
  • Fluency in English and Portuguese
  • Other Required:
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