Ensure timely, quality site activation for assigned countries/sites.
Prepare Clinical Trial Applications and submissions to authorities.
Interact with CA/EC for study submissions and responses.
Maintain project plans, trackers, and regulatory intelligence tools.
Develop start-up plans, IMP release requirements, and essential document reviews.
Partner with the assigned site CRA to align communication and activate sites.

🎯 Requirements

Bachelor’s degree in life sciences or RN or equivalent.
1+ year as Regulatory or Start-Up specialist in CRO/pharma.
Experience with regulatory submissions and ICH-GCP.
Strong communication and organizational skills.
Fluent in English.
Experience with milestone tracking tools/systems.

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