Ensure site activation readiness and risk mitigation for assigned sites.
Prepare Clinical Trial Application forms and submission dossiers for authorities and EC per ICH-GCP.
Interact with CA/EC for study purposes and responses.
Provide regular CA/EC submission updates to Start Up Lead and PM.
Maintain project plans, trackers, and regulatory intelligence for start-up.
Coordinate with site CRA to align communication and site activation efforts.

🎯 Requirements

Bachelor’s degree in life sciences or RN; healthcare background.
1+ year as Regulatory or Start-Up specialist in CRO/pharma.
Pharmacy qualification or pharmacist experience beneficial.
Strong communication and organizational skills; English fluency.
Experience with regulatory submissions, CA/EC timelines, and TMF.
Advanced degree (MD/PhD/PharmD) or RAC/regulatory science preferred.

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