Degree in relevant life science discipline Required Experience :5-8 years relevant experience Required technical skills :Regulatory in country affiliate activityLocal stakeholder interfaceOperational liaison with 3rd PartiesRegulatory Assessment for Quality and Safety changes (inc labelling updates and non CMC administrative changes)Creation/update Country Label DeviationUpdate and approval local artworksProvision of local reg intelReg review local promotional materials via PromoMatsLocal Regulatory SOP review and updateRegulatory activities for launchCoordinate of Response to QuestionsPreparation/update Product InformationFee calculationPreparation /update local abbreviated PI (if applicable)Preparation of Renewal Procedure eg local document identification and preparationPreparation for Variations inc. RtQs, requesting/securing centrally provided documentationPreparation for Annual Safety Updates/HA instructed safety updatesRegulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of MAsInforming reliant markets of changes to reference productPQR local submissions (when applicable)Responding to requests from Med info (when applicable)Provision of regulatory data for PV reportingProviding support during external and unannounced audits.Responding to internal requests for technical and/or regulatory information.Assisting with license applications as required.Preparation and submission of Technical/Site Transfer ApplicationsAssisting with the preparation of Marketing Authorisation ApplicationsEnsuring compliance with all regulatory processes, in readiness for both internal and external audits.Ensuring compliance with the regulations of the assigned Countries within Australia RegionUse a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etcA proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budgetGeneral regulatory administration duties and compliance requirementsManagement of artwork generation/ labelling/creation/update of product information (at least 3-5 years)Additional experience and/or skills :Experience of Medical Devices would be beneficialExperience of other EU region would be beneficialPrevious experience of people management/coordination would be an advantageExperience of PV would be beneficialExperience of promotional/non-promotional activities would be an advantage (at least 3-5 years)Good IT skills/knowledgeGood organizational skillsPro-active attitude and able to work on own initiative as well as part of a teamAbility to prioritize different workloads/multi-taskPersonal responsibility for ensuring a high standard of workHands-on experience of product launches within [insert area]#J-18808-Ljbffr
