Global Regulatory Affairs Specialist
5 giorni fa
Direct message the job poster from Jefferson Wells ItaliaSCOPO 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.Regulatory Submissions & Documentation:Prepare, 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 regulatory requirements in different regions.Regulatory Compliance & Strategy:Support the development and implementation of global regulatory strategies for assigned products in collaboration with internal teams.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 to 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.Requisiti:Good knowledge of EMA, ICH and FDA regulations, guidelines, and regulatory processes regarding drug development, approval, and maintenance of marketing authorisations.Strong organisational skills; good commercial and product awareness.Sound administrative and systems background.Minimum 3 years of experience in Regulatory Affairs in the Pharmaceutical Industry.Master Degree in scientific subject, preferable in Pharmacy or related. Master in Regulatory Affairs is considered a plus.Fluent in English, spoken and written.Master of Office.Familiarity with eCTD submission, compilation and publishing using specific tools.Seniority levelAssociateEmployment typeFull‑timeJob functionPublic Relations, Writing/Editing, and Accounting/AuditingIndustriesHuman Resources, Pharmaceutical Manufacturing, and Research Services#J-18808-Ljbffr
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Global Regulatory Affairs Specialist
2 settimane fa
Milano, Italia Alfasigma A tempo pienoA global healthcare company based in Italy seeks a Non-Pharma Global Regulatory Affairs Specialist to manage regulatory documentation for projects in compliance with EU regulations.The role involves collaboration with internal teams and contributes to regulatory strategies for new projects.Candidates should have at least 5 years of experience in Regulatory...
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Global Regulatory Affairs Specialist
3 giorni fa
Milano, Italia Jefferson Wells A tempo pienoJefferson 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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Global Regulatory Affairs Specialist
1 settimana fa
Milano, Lombardia, Italia Jefferson Wells Italia A tempo pienoJefferson 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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Global Regulatory Affairs Specialist
1 giorno fa
Via Milano, Italia Jefferson Wells A tempo pienoJefferson 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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Global Regulatory Affairs Specialist
7 giorni fa
Milano, Italia Jefferson Wells Italia A tempo pienoDirect message the job poster from Jefferson Wells ItaliaSCOPO 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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Global Regulatory Affairs Specialist
1 giorno fa
milano, Italia Jefferson Wells A tempo pienoJefferson 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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Global Regulatory Affairs Specialist
2 giorni fa
Milano, Italia Jefferson Wells A tempo pienoJefferson 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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Global Regulatory Affairs Specialist
1 settimana fa
Milano, Italia Jefferson Wells Italia A tempo pienoDirect 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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Global Regulatory Affairs Specialist
1 giorno fa
Via Milano, Italia Jefferson Wells A tempo pienoJefferson 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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Global Regulatory Affairs Specialist
5 giorni fa
Via Milano, Italia Jefferson Wells Italia A tempo pienoDirect 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...
