Regulatory Affairs Specialist_Temporary Replacement (ITALFARMACO)

Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross-functional teams. RESPONSABILITIES: Regulatory Submissions & Documentation Prepare, compile, revise, and submit global regulatory dossiers for new Marketing Authorization Applications (MAAs), variations, renewals, and lifecycle management activities. Collaborate in the preparation and/or revision of global regulatory submissions to ensure completeness, accuracy, alignment with company objectives, and compliance with the latest local and international regulations. Prepare documentation and submissions to Health Authorities, either directly or through local partners, ensuring regulatory compliance and supporting efficient product registration and maintenance. Support labelling and change control processes to ensure timely and comprehensive review and approval of packaging components (cartons, labels, Physician Insert, Patient Insert, Medication Guides). Manage other legal documentation required for registrations, such as Certificates of Pharmaceutical Product (CPPs). Maintain accurate and up-to-date regulatory documentation and regulatory files in accordance with global standards. Input regulatory intelligence, requirements, and submission data into relevant regulatory systems/databases, ensuring data accuracy and consistency. Regulatory Compliance, Strategy & Lifecycle Management Support the implementation of global regulatory strategies for assigned products to achieve regulatory approvals and maintain compliance throughout the product lifecycle. Advise and collaborate with cross-func.

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