Senior Director Regulatory Affairs

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.

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 requirements
Drive scientific consultations, pre‐submission meetings, and interactions with Italian authorities
Oversee labeling, packaging, promotional material review, and HCP communication
Monitor Italian regulatory developments and communicate implications to global teams
Represent Regulatory Affairs internally and externally; contribute to industry associations
Lead and optimize regulatory processes, SOPs, audits, inspections, and compliance
Manage quality defects, recalls, and regulatory licenses
• Provide leadership, resource planning, and strategic direction for the Italian RA organization

Required Qualifications:

Master's or PhD in a scientific or medical discipline
10+ years of regulatory leadership experience in pharma/biotech
Strong knowledge of Italian and EU regulatory frameworks
Oncology experience preferred
Excellent communication skills in Italian and English
Proven ability to analyze scientific information and engage effectively with authorities
Ability 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