Regulatory submission manager

Job description

Regulatory submission manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Regulatory 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...