ResponsibilitiesEnsure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirementsManage international regulatory submissions according to company strategy and ensure registration deadlines are metRespond to Health Authorities’ queries and deficiencies in a timely mannerLiaise with other departments to support the timely introduction of new products into marketsWork as part of a team dealing with global registrations and providing regulatory support to all operational departments within the companyMaintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely mannerCommunicate Health Authority approvals/final decisions to the relevant departmentsBuild departmental awareness of local regulatory requirements in global marketsAssess the impact on existing files when new regulatory requirements are issuedArchive the registration documentation according to internal standards; introduce and regularly update the internal RA databasePerform assigned tasks to the highest standard and in accordance with established internal timelines and guidelinesDossier managementAssist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategiesProactively inform the RA Manager and other involved functions regarding all identified risks related to the planned MAASubmit Marketing Authorisation Applications (MAA) to Health Authorities according to the registration plan and company\'s registration strategyObtain scientific advice from Health Authorities by liaising with the Health Authorities and preparation of all the required documentsAttend regulatory strategy or submission meetings with Health AuthoritiesContribute to reviewing regulatory aspects of in-licensing contracts and agreementsCompilation of registration dossiers for identified marketsReview of regulatory submissions/MAAs for accuracy, completeness and compliance with EU or relevant Health Authority regulations and relevant guidelines; ensure that all specific national requirements are metCompile the hard copy and/or eCTD of the registration dossier (depending on specific in-country registration requirements)Identify and then obtain any deficient information in order to complete the compilation within the allocated time frameRaise all identified risks related to the quality of the dossier in order to meet submission deadlines, without compromising the quality of the submissionAuditing the licensor’s registration dossier vs. EU guidelines and, if relevant, specific national requirements as part of the in-licensing process in order to evaluate and assess its acceptability and identify all future possible major Health Authority deficienciesSubmission and registration processPrepare, as per internal process, the data needed to make all required registration fees in a timely mannerDispatch the documentation in the appropriate manner in order to deliver it to the relevant Health Authority or local Regulatory Service Provider or local Marketing Authorisation Holder (MAH); ensure the delivery is confirmedAnswer all queries received from Health Authorities during the validation phase of registrationEnsure all internal RA database are updated with any new specific national requirementsCoordinate and communicate trade name rejectionAddress all deficiencies identified by the Health Authority in an appropriate manner within the required timelines. During the Response to Questions preparation liaise closely with internal/external contacts, relevant departmental staff and Health Authorities to ensure efficient and timely product registrationCommunicate any change in status for assigned tasks. Raise all identified risks related to the deficiencies from Health Authorities which might cause negative decision of procedure or delays in timelinesMonitor planned approval timelines and if necessary intervene in order to facilitate approval and minimise registration delaysOrganise national translations in efficient and organised manner in order to meet strict registration timelines during national phase of registration (EU: MRP, DCP, CP, Work-sharing procedure)Co-ordinate national phase with the Health Authority, Artwork Department, PV Department, local affiliate or local Regulatory Service Providers/local MAH to resolve any issues related to national translation of product information in order to obtain Marketing AuthorisationReview Marketing Authorisation/Registration Certificates for errors and ensure successful correctionUpdate and archive registration documentation according to the internal standardsCommunicate MA approvals to all relevant personnel and update the relevant entries in all RA databasesOrganise the handover of required data from dossier and registration process to allow efficient preparation for the first launch and marketingMaintain the assigned products’ marketing authorisations in MarketsProvide regulatory input to product lifecycle planning, including building of renewal plans, assessing the risk related to \"sunset clause\" provisionProvide regulatory assessment and strategy and regulatory impact assessment for change controlsAnalyse the input of cumulative product changes to current product submissionsImpact assessment on existing files when new requirements are issuedReview, prepare and compile the registration documentation required to maintain MAs, for example variations (required internally or requested by Health Authorities), any supplements to dossiers, notification, renewalsInform other relevant functions about all relevant submissions e.g. variations, renewal and their predicted approval timeCompile the regulatory component of annual product quality review (PQR) and PSUR/PBERProjects and team workingWork as part of a team dealing with global registrations and provide regulatory support (guidance and strategy) to multi-disciplinary team and all operational departments within the companyLiaise with the Global IP and (if required) other Hubs with respect to Global dossiers and related projects in order to ensure required documentation is available on time, fully complete and accurateReport monthly on status of assigned projectsActing as a mentor and supervisor to less experienced staffIf necessary substitute and/or give support to the departmental colleagues in order to ensure all tasks assigned to the team are timely performedShare and exchange knowledge gained from everyday work and trainings with departmental staffRegulatory Good PracticePerform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all timesEnsure that any regulatory changes communicated to the pharmaceutical industry by Regulatory Authorities are raised to the RA Manager in order that they are implemented without delay within the relevant departmentInvestigate and maintain regulatory knowledge within the departmentProvide regular training within the department regarding specific regulatory affairs topics assigned by the departmental manager and communicate this topic to the RA DepartmentContribute in development of new regulatory policies, processes, rules of cooperation and SOPs and train key personnel on themEducation & Job Related Work Experience RequiredLife sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degreeMin 4-5 year experience in a regulatory affairs environmentMin 4-5 year experience in the pharmaceutical industryDetailed knowledge of EU and other regions current registration requirements for dossier preparation and procedure runningSolid knowledge of specific national requirements in EU and other regionsKnowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.)Seniority levelAssociateEmployment typeFull-timeJob functionHealth Care ProviderIndustriesPharmaceutical Manufacturing
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