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hace 3 meses
Global Regulatory Affairs ManagerWe're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products.
Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this roleThe Regulatory Affairs Manager will be responsible for overseeing the regulatory process for products, from development to post-market approval.
He/she will ensure compliance with applicable regulations and standards.RESPONSIBILITIESPreparation (compile and/or write the modules of an eCTD file, mainly Module 1 and 3), review and submission of regulatory documents throughout the product lifecycle (initial marketing authorisation submission, variations, notifications and renewals) to regulatory agencies to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standardsPreparation, review and submission of responses to regulatory agency inquiriesMonitor and set timelines for licence variations, notifications and renewal approvalsEnsure compliance with regulatory requirements and guidelinesMonitor and update regulatory documentation as necessary to keep company in compliance from a regulatory perspectiveParticipate in meetings with regulatory agencies as neededParticipate in meetings with manufacturers as neededAdvise manufacturers on regulatory requirementsDocument and track regulatory submissions and regulatory authority approvalIs responsible for review, proof reading and approval of artwork of packaging materials to ensure compliance with regulatory requirementsIs responsible for the preparation of Summary of Product Characteristics, Patient Information Leaflets and labelling according to the Quality Review Documents (QRD) formatCollaborate with cross-functional teams including RD, Quality, and Marketing to ensure that all regulatory requirements are met throughout the product lifecycleProvide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of productsKeep up to date with national and international legislation, guidelinesMaintains RA archives (electronically)EXPERIENCE PROFILEScientific background is a must – master's degree in pharmaceutics, health care, life sciences or related fields preferred5 + years of experience in a similar role, preferably in an international environmentMinimum of 5 years of experience in regulatory affairs within the pharma industryA good knowledge and preferably experience with pharmaceutical development and validation of processesExperience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentationExperience in interacting with regulatory authoritiesExcellent planning and time management skillsA good knowledge of relevant European guidelines, applicable legislation and regulationsFluent communication skills in English (written and oral), also in Dutch is an assetCOMPETENCIESStrong team player, with the ability to work effectively in team setting and interaction with people of different seniority and functional backgroundsAbility to work independently and as part of a teamAbility to offer ideas and accept ideas of othersHighly ethical, honestly, reliability, accountability, loyaltyAbility to handle and enjoying complex and changing environmentsPositive "can do" attitudeAbility to consistently meet deadlines, remain organized, adaptable and autonomousGood communication and presentation skillsEnglish language skills (spoken and written), Dutch is a bonusAbility to work concurrently on projects, each with specific instructions that may differ from project to projectIf this role sounds interesting to you, then please apply or reach out to ****** #J-18808-Ljbffr
