Local Regulatory Responsible (LRR) (m/f/x)

• Local Regulatory Responsible (LRR) (m/f/x) - Italy
• Department: Regulatory Affairs

The Opportunity

In this role, you will serve as the primary regulatory representative for Italy, ensuring compliance with local regulations, leading interactions with Health Authorities, and supporting product registrations and lifecycle management activities.

You will work closely with regional regulatory teams, commercial operations, and external stakeholders to drive regulatory excellence and business success.

The Role

• Provide local regulatory expertise and input to support the development and execution of regulatory strategies for new product registrations and lifecycle management activities.
• Review promotional materials and provide regulatory guidance to ensure compliance with local regulations.
• Monitor and communicate progress of regulatory projects to relevant stakeholders.
• Ensure compliance with Italian regulatory requirements and evolving legislation.
• Support audit and inspection readiness activities and ensure timely implementation of corrective and preventive actions (CAPAs).
• Monitor changes in the regulatory landscape and communicate emerging requirements and industry trends to internal stakeholders.
• Participate in regulatory meetings, industry forums, and trade associations to represent company interests and share insights.
• Maintain compliance-related KPIs and ensure regulatory information systems (RIMS) remain accurate and up to date.
• Serve as the primary contact for Italian Health Authorities and regulatory stakeholders.
• Build and maintain strong relationships with Health Authorities, industry groups, and trade associations.
• Lead local regulatory interactions related to licenses, submissions, and market access initiatives.
• Act as the regulatory representative for local Commercial Operations, providing strategic guidance and business-focused regulatory support.
• Coordinate and prepare country-specific regulatory documentation, including Module 1 and other local requirements.
• Support regional regulatory teams in submission planning and execution aligned with local requirements and business priorities.
• Track and communicate the status of regulatory submissions with local Health Authorities.
• Ensure regulatory compliance of product labeling, including Sm PC, PIL, and packaging materials.
• Manage translation activities and required labeling updates.

Your Skills and Experience

• Bachelor’s degree in a relevant scientific discipline such as Biology, Chemistry, Pharmacy, or a related field, or equivalent education and experience.
• Advanced degree (Master’s or Ph D) in a scientific, healthcare, legal, or regulatory discipline preferred.
• Regulatory Affairs Certification (RAC) or other relevant professional certification is desirable.
• 3-5+ years of regulatory affairs experience in a Health Authority-facing role within the pharmaceutical, biotechnology, or healthcare industry.
• Strong knowledge of Italian regulatory requirements and regulatory processes.
• In-depth experience managing local Health Authority interactions.
• Experience managing regulatory submissions and product lifecycle activities.
• Demonstrated project management and cross-functional leadership experience.
• Experience collaborating with commercial and business stakeholders in a matrix environment.
• Ability to adapt and perform effectively in a rapidly changing environment.
• Fluency in Italian and English, both written and spoken.
• Strong understanding of local health authority interactions and regulatory compliance requirements.
• Excellent organizational, prioritization, and time management skills.
• Strong stakeholder management and influencing skills.
• Ability to work independently while collaborating effectively across global teams.
• Strong problem-solving skills with the ability to escalate issues appropriately.
• Proficiency in Microsoft Office applications.
• Ability to thrive in a complex global matrix organization.

What we offer

We offer an open-ended contract (Tempo Indeterminato) regulated by the CCNL Chimico Farmaceutico, with a gross annual salary range of €45,000 - €55,000, commensurate with experience and qualifications.

In addition, we provide an outstanding benefits package, an annual merit-based reward process, and an individual development plan to support your professional growth and career progression.