Senior Regulatory Affairs Officer - Compliance - Dublin

Job DescriptionTimely compilation of registration dossier in accordance with standards and corporate requirementsManage international regulatory submissions according to company strategy and registration deadlinesTimely answering of Competent Authorities (CA's) queries and deficienciesCooperation with other functions and CA's' to support New Product IntroductionWork as part of a team for global registrations and regulatory support to all Client operational departments, in particular Global IP and other hubs responsible for Global dossiers and related projectsMaintain product MA's via timely variation and renewal submissions and approvalsBuild and develop departmental awareness of local regulatory requirements in global marketsAssess impact on existing MA's when new regulatory requirements are issuedArchiving of regulatory documentation in accordance with internal standardsData input and maintenance of the internal RA databasesPerform assigned tasks to the highest standard and in accordance with established internal timelinesRequirementsLife sciences (BSc in Chemistry/ Biology, etc.)
or pharmacy degree4-5 year experience in a regulatory affairs environment4-5 year experience in, and general knowledge of, the pharmaceutical industryDetailed knowledge of EU and other regions current registration and dossier requirementsDeep knowledge of specific national requirements in EU and other regionsExperience with IT tools specific for RA and pharmaceutical sectorPackage€40K+, negotiable depending on experiencePermanent PositionCompany Benefits