PFor an innovative international biotechnology company, we are currently looking for an highly experienced Senior Director Regulatory Affairs (F/M/X) to lead the regulatory strategy and operations in Italy and support the preparation of a highly promising oncology launch. /ph3The Opportunity: /h3pThe role provides strategic guidance across assigned projects, ensures full compliance with Italian/EU regulations, and collaborates closely with global and European regulatory teams supporting both early‑stage and marketed products. As part of the local Management Team, the Senior Director works cross‑functionally with medical affairs, clinical development, marketing, and other key functions. /ph3Key Responsibilities: /h3ulliLead all regulatory activities for Italy in alignment with national and EU requirements /liliDrive scientific consultations, pre‑submission meetings, and interactions with Italian authorities /liliOversee labeling, packaging, promotional material review,

and HCP communication /liliMonitor Italian regulatory developments and communicate implications to global teams /liliRepresent Regulatory Affairs internally and externally; contribute to industry associations /liliLead and optimize regulatory processes, SOPs, audits, inspections, and compliance /liliManage quality defects, recalls, and regulatory licenses /liliProvide leadership, resource planning, and strategic direction for the Italian RA organization /li /ulh3Required Qualifications: /h3ulliMaster’s or PhD in a scientific or medical discipline /lili10+ years of regulatory leadership experience in pharma/biotech /liliStrong knowledge of Italian and EU regulatory frameworks /liliOncology experience preferred /liliExcellent communication skills in Italian and English /liliProven ability to analyze scientific information and engage effectively with authorities /liliAbility to thrive in a dynamic, fast‑paced environment; willingness to travel up to 30% /li /ul #J-18808-Ljbffr

Senior director regulatory affairs

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