Global Regulatory Affairs Specialist

10 ore fa

Lazio, Italia Jefferson Wells A tempo pieno

Jefferson Wells, per conto di un'importante azienda farmaceutica, è alla ricerca di un Global Regulatory Affairs Specialist.SCOPO DEL RUOLO :Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies, with particular reference to EU.This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross-functional teams.RESPONSABILITA'Regulatory Submissions & DocumentationPrepare, compile, and submit global regulatory dossiersFor new marketing authorization applications (MAAs), variations, renewalsEnsure timely and accurate submission of documents in compliance with global regulationsSupport the labelling and change control processes to ensure timely and comprehensive review and approval of all packaging components (e.g., cartons, labels, Physicians Insert, Patient Insert, and Medical Guides)Maintain high-quality regulatory documentation, ensuring it is consistent, accurate, and compliant with the regulatory requirements in different regionsRegulatory Compliance & StrategySupport the development and implementation of global regulatory strategies for assigned products in collaboration with internal teams to ensure product approval across multiple marketsMonitor regulatory changes and industry trends to ensure compliance with evolving guidelines and support the updating of regulatory strategiesAdvise cross-functional teams (R&D, Quality Assurance, Manufacturing, etc.) on regulatory requirements and strategies for market approval / lifecycle managementContribute to the creation and maintenance of the Regulatory Affairs quality system, collaborating on the definition of processes and implementation of global standard proceduresMaintain knowledge of global regulatory requirements and trends, sharing relevant updates with internal teamsContribute to regulatory intelligence activities and provide insights into global regulatory landscape developmentsTrack regulatory submissions, approvals, and regulatory activities using tracking systems and ensure timely reporting to management#J-*****-Ljbffr

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