Global ResponsibilitySupport new regulatory submissions and assisting with the lifecycle management of the existing portfolio making sure that any variations and/or renewals will be submitted in time to ensure regulatory compliance.Specific ResponsibilitiesSupport and provide the necessary documentation to local affiliates and clients for national submissionsSupport and provide the necessary documentation to local affiliates and clients to answer the LoDs with the aim to receive the MA as soon as possiblePrepare the necessary documentation needed for submission of administrative/ quality and safety variationsSubmit renewals in timely manner and that timelines are communicated with all partnersArchiving of essential documents, such as product information and ensure quality part of the dossier are archived and updated in line with company procedureMake sure that the essential information from the dossier post approval are shared with implicated departments according to relevant proceduresMake sure that the regulatory database is up to date for his/her projects in the region.Stay up to date on latest regulatory requirements in the region. Inform interested parties, such us commercial, business development and top management on the regulatory status in respective area