Global Regulatory Affairs Specialist

Jefferson Wells; Milano; In loco; EUR 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

Un'importante azienda farmaceutica sta cercando un Global Regulatory Affairs Specialist. Il candidato sarà responsabile della preparazione e gestione di dossier regolatori globali, garantendo la conformità a normative internazionali, con particolare attenzione all'UE. È richiesta una solida esperienza nella gestione delle approvazioni normative e la capacità di lavorare con team cross-funzionali. Questo ruolo offre un'opportunità unica di influenzare strategicamente il lancio dei prodotti sul mercato internazionale.

Competenze

• Esperienza nella preparazione e gestione di dossier regolatori globali.
• Buona conoscenza delle normative UE e internazionali.
• Capacità di lavorare con team cross-funzionali.

Mansioni

• Preparare e inviare dossier regolatori globali.
• Supportare strategie di regolamentazione per l'approvazione dei prodotti.
• Monitorare i cambiamenti normativi e le tendenze del settore.

Descrizione del lavoro

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 & 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 the 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 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