Global Regulatory Affairs Specialist

1 giorno fa

Via Milano, 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 dossiers For new marketing authorization applications (MAAs), variations, renewals Ensure timely and accurate submission of documents in compliance with global regulations Support 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 markets Monitor regulatory changes and industry trends to ensure compliance with evolving guidelines and support the updating of regulatory strategies Advise cross‑functional teams (R&D, Quality Assurance, Manufacturing, etc.) on regulatory requirements and strategies for market approval / lifecycle management Contribute to the creation and maintenance of the Regulatory Affairs quality system, collaborating on the definition of processes and implementation of global standard procedures Maintain knowledge of global regulatory requirements and trends, sharing relevant updates with internal teams Contribute to regulatory intelligence activities and provide insights into global regulatory landscape developments Track regulatory submissions, approvals, and regulatory activities using tracking systems and ensure timely reporting to management#J-18808-Ljbffr

  • Global Regulatory Affairs Specialist

    1 giorno fa

    Via Milano, 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...

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    Via Milano, Italia Jefferson Wells Italia A tempo pieno

    Direct message the job poster from Jefferson Wells Italia 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...

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    Milano, Italia Jefferson Wells A tempo pieno

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    7 giorni fa

    Milano, Italia Jefferson Wells Italia A tempo pieno

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    milano, Italia Jefferson Wells A tempo pieno

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