Clinical Trial Application Submission Manager (CTA-SM)

Job description

Regional regulatory submission manager (EU CTR) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team. . What you will be doing: - Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development - Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities - Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, polic...