Job Description
An exciting new role with ICON within our regulatory team working on high profile Pharma projects. The Regional CTA Submission Manager (CTA-SM) is accountable for working with contributing to business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for EU CTR and drive submission teams towards the timely delivery of globally compliant submission-ready components. Drives regional submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required.The role requires solid hands-on experience in Clinical trial applications under EU CTR on the regional or Local Level and Strong country experience in Ukraine.
About ICON
An exciting new role with ICON within our regulatory team working on high profile Pharma projects with a client with which ICON shares a culture of innovation.