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.
Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO
Fluency in Hungarian language as this position will support Hungarian sites.

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