Senior Director Regulatory Affairs
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Senior Director Regulatory Affairs subrosa Health & Capital group•Palermo, Sicily, IT
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 xlwpduy 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%
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