Senior Director, Regulatory Operations and Publishing will establish appropriate internal system and vendor management of external operations depending on the level of need for project execution. Will work effectively with product development teams as a cross-functional R& D operations leader in all aspects of drug development, technology implementation and process as well as manage vendor alliance with external vendors as needed for other publishing activities. Will oversee the internal publishing and document management systems and be responsible for the implementation of Veeva vault regulatory. Will develop and manage a small internal group of publishers to support regulatory and clinical functions and development activities, responses to health authorities and regulatory submissions. This individual will help implement R& D operations planning strategies and organizational change management.
Regulatory Operations & Publishing Senior Director will play a critical and leading role in establishing internal publishing and operations capabilities and be responsible for vendor and alliance management as well as service level agreements with any external publishing vendors as needed. Support the daily activities to deliver to Health authorities regulatory documentation in compliance with regulations.