10 set - Italia
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. Se sta pensando di inviare una candidatura, si ricordi di premere il pulsante apposito dopo aver letto l'intera descrizione.
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 xrdztoy 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% Interest
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