Job Description
ICON is seeking a Regulatory Affairs CTA Submission Manager to drive regional submission management strategy and activities for assigned protocols while partnering with study teams. Responsibilities include managing required regulatory activities, deliverables associated with CTA submission development, authoring Annex I, attending meetings to advocate realistic deliverable timelines, and supporting global team efforts. The CTA Manager will also prepare and support submissions to HA/Regional CTA Hub, coordinate translations, manage the compilation for core package build, and escalate any issues impacting submission builds. Candidates should have experience in EU CTR and hands-on submission experience using CTIS.
About ICON
ICON is a company that shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market.