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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

Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent
A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
At least 2 years of relevant experience.
Previous experience working as a Regulatory or Start Up specialist in either a CRO or
Strong communication and organizational skills.
Experience using computerized information systems, electronic spreadsheets, word processing and

Regulatory and Start Up Specialist

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