Required technical skills:
Previous experience of people management/coordinationLifecycle maintenance experience / CMC experience in Europe / CIS regionProviding support during external and unannounced audits.Responding to internal requests for technical and/or regulatory information.Request payment of fees and subsequent approval (administrative co-ordination)Assisting with license applications as required.Preparation and submission of documentation for post-approval applications including, but not limited to, variations Renewals, MAH Transfers/COAsPreparation and submission of Technical/Site Transfer ApplicationsAssisting with the preparation of Marketing Authorisation ApplicationsCMC authoring / Perfroming due dilgenace of dossierMonitor and maintain up-to-date knowledge of national and European and CIS guidelines/legislation.