Compilation , review  of dossier for US, EU, AU, Canada & IL market Review of query response prepared and compiled by regulatory associates Manage all the activities related to EU & AU life cycle management . Submission ,  Tracking and approval of the variation as needed Reviewing of the plant change control and established the variation strategy  for submission Manage all the activities pertaining to dossier submission for aforesaid markets . Review of all the documents received from stake holder for  dossier compilation , Query response and Life cycle management Allocation of projects to regulatory associate & manage the team for all the  regulatory submission activities