Remote Regulatory affairs Jobs • Site Start-up

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities, responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites, and mitigating any risks.

Responsible for delivery of site activation readiness, preparation of Clinical Trial Application Forms, and interaction with CA/EC for study purposes. Providing updates about submissions, maintaining project plans, and customizing Patient Information Sheets. Act as SME for collection and maintenance of site level critical path to Site Activation data points. May support the clinical team performing Pre-Study Site Visits.