Head of Regulatory Affairs Italy
Descrizione dell'offerta
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