Global Regulatory Submission Manager

Job description

Global Regulatory Submissions Manager 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 As a Global submission manager at ICON, you will contribute to drug development as part of the Regulatory Affairs team. This position serves as the regional regulatory representative within study teams, responsible for obtaining and maintaining clinical trial authorizations for compounds in development or marketed products under investigation for new indications What You Will Do: You will oversee regulatory affairs workstreams, ensuring deliverables meet quality and timeline expectations. Key responsibilities include: - Lead the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, ensuring full compliance with local and global regulatory requirements. - Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and timelines. - Provide strategic input to clinical st...