Descrizione:
In this role you lead the Italian Regulatory Affairs team to align local submissions with global strategy and engage with authorities. You shape local HA engagement, ensure compliant filings, and support clinical trials when needed. You collaborate with cross-functional partners to translate regional plans into country execution. You drive leadership and development within your team, delivering high-performance, compliant regulatory outcomes that enable patient-centric innovations.Lead and manage the Regulatory Affairs team in Italy, coordinating day-to-day activities
Steer local submission management from planning to finalization
Define health authority engagement strategy and serve as primary local contact
Maintain relationships with local health authorities and incorporate insights into planning
Represent the country in industry associations
Develop country product plans aligned with global/regional strategy
Coordinate with local, regional, and global partners and stakeholders
Provide regulatory support for clinical trials where applicable
Review and approve promotional material and ensure local HA submissions as required
Coach and develop team members and promote proactive, efficient work
Lead regional process projects or initiatives and participate in the Regional Regulatory Leadership Team
10-15 years of experience in Regulatory Affairs (local RA proficiency)
Strong knowledge of EU regulations and Spanish regulatory context
Well-established network with local Health Authorities
Strong stakeholder, project management, and communication skills
Ability to manage multiple priorities in a fast-paced environment
Change management and process improvement aptitude
Fluent in Spanish and English; Italian language knowledge required
Ability to interact with all management levels
Excellent time management and multi-tasking abilities
Advanced skills in MS Office and business applications