Evolving Roles for Submission Managers

The field of submission or dossier management has changed significantly in recent years. New electronic submission requirements, new technologies and varied agency implementation schedules for eCTD (electronic Common Technical Document) have added complexity and confusion to the submission management process. These factors have also changed the role of the submission manager and the skill sets required to be successful at submission management. This paper will discuss the changes that have occurred and how they impact the operational aspects of good submission management.