07 set - Ega
subrosa Health & Capital group
For 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.Legga attentamente tutte le informazioni su questa possibilità, quindi utilizzi il pulsante di candidatura sottostante per inviare il suo CV.The Opportunity: The 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.Key Responsibilities:Lead all regulatory activities for Italy in alignment with national and EU requirementsDrive scientific consultations, pre‐submission meetings, and interactions with Italian authoritiesOversee labeling, packaging, promotional material review,
and HCP communicationMonitor Italian regulatory developments and communicate implications to global teamsRepresent Regulatory Affairs internally and externally; contribute to industry associationsLead and optimize regulatory processes, SOPs, audits, inspections, and complianceManage quality defects, recalls, and regulatory licensesProvide leadership, resource planning, and strategic direction for the Italian RA organizationRequired Qualifications:Master's or PhD in a scientific or medical discipline10+ years of regulatory leadership xysqume experience in pharma/biotechStrong knowledge of Italian and EU regulatory frameworksOncology experience preferredExcellent communication skills in Italian and EnglishProven ability to analyze scientific information and engage effectively with authoritiesAbility to thrive in a dynamic, fast‐paced environment; willingness to travel up to 30%Interested or know someone who might be a strong fit?I would be delighted to connect for a confidential conversation
10 set - Milano
During S.p.A. Filiale di Milano Cadorna
10 set - Turbigo
Altro
10 set - Ficarazzelli-bagni Italia
Laboratorio Giepi
10 set - Cremona
agap2 Italia