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.

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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 xrdztoy 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

📌 Senior Director Regulatory Affairs (Roma)
🏢 subrosa Health u0026 Capital group
📍 Roma