Regulatory Affairs Manager

THE POSITION

From early development through lifecycle management, regulatory expertise plays a critical role in bringing medicines to patients. We are looking for an experienced Regulatory Affairs Manager to join our Italian Regulatory Affairs Department and contribute directly to the success of both our products and pipeline.

As a key regulatory partner, you will apply advanced regulatory expertise to support business programs for the prescription regulated products and guide cross‑functional teams, combining strategic thinking with strong execution.

Responsibilities:

• Define, communicate and execute local regulatory strategies, ensuring alignment with business priorities and adherence to agreed timelines to obtain and maintain Regulatory Authority approvals.
• Act as strategic regulatory representative on asset teams, providing proactive regulatory input and advice throughout development and lifecycle activities.
• Develop and maintain strong, effective relationships with internal stakeholders and external partners.
• Ensure regulatory compliance throughout the product lifecycle, monitoring regulatory changes, assessing their impact and implementing required updates.
• Actively contribute to local inspection readiness, supporting preparation and execution of inspections relevant to areas of responsibility.
• Ensure compliance of company communication and promotional materials with applicable local regulatory requirements.

Requirements:

• Scientific degree.
• Minimum 5 years of experience in Regulatory Affairs within a pharmaceutical company within prescription-only medicines
• Solid knowledge of Italian and European regulatory requirements and procedures.
• Very good spoken and written in Italian and English.
• Excellent written and verbal communication skills.
• Strong business acumen and ability to operate in complex, cross‑functional environments.
• Well‑developed time management and prioritization skills.
• Strong analytical skills and problem‑solving capability.

What we offer:

• For this position we offer a permanent contract.
• Free access to the company canteen and ticket restaurants when working remotely .
• A range of benefits for you physical, financial, social and mental wellbeing.
• A support to develop your own professional and personal path that will guide you through our full range of development programs including our full range of development programs. 

We warmly welcome applications from candidates belonging to protected categories, in accordance with Law 68/99.

We foster a workplace built on respect, trust, and empathy—free from discrimination. We are powered by our people, and we believe that our differences are our strengths. Everyone is valued, respected and empowered to be themselves.