Senior Director, Regulatory Affairs, Italy

Per essere preso/a in considerazione per un colloquio, la preghiamo di assicurarsi che la sua candidatura sia pienamente in linea con le specifiche del lavoro riportate di seguito.
In this role you lead regulatory strategy and execution for Italy, aligning with EU and ICH requirements to support early and marketed products. You will partner with global and regional teams to ensure compliant regulatory activities, materials, and communications. You influence guidelines, inspections, and process improvements while mentoring a local affiliate and contributing to the international regulatory community. This position offers impact across product development, regulatory strategy, and cross-functional collaboration within a mission-driven oncology company.

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- Provide strategic input on regulatory activities for assigned projects and territories per ICH, Italian and EU regulations
- Coordinate creation of risk mitigation materials and healthcare professional communication




- Ensure packaging and labeling information is updated per regulatory requirements
- Review and approve promotional materials
- Represent regulatory function in internal and external meetings with regional/global teams
- Monitor Italian regulatory guidelines and communicate updates to project teamsMaintain knowledge of Italian and EU regulatory requirements and contribute to new guidelines
- Lead creation and maintenance of regulatory procedures, SOPs, and work instructions
- Manage affiliate inspections, audits, defects, recalls, and distribution licenses
- Provide vision and direction for the country-level Regulatory Affairs organization
- Plan and optimize resources and budget for portfolio development and regulatory changes
- Ensure adequately trained and well-staffed affiliate, adhere to Core Values
- Understand regulatory requirements for field-based customer engagement
- Participate in industry associations and regulatory societies
- Drive local/global p

📌 Senior Director, Regulatory Affairs, Italy (Cusano)
🏢 Experteer Italy
📍 Cusano