Local Regulatory Affairs Lead, Milano, Italy

Alexion Pharmaceuticals,Inc.; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Alexion Pharmaceuticals is seeking a Local Regulatory Affairs Lead in Milan, Italy, to manage regulatory activities for its portfolio. This role requires a pharmacist with extensive experience in regulatory affairs and a strong understanding of compliance standards. The Lead will work closely with local authorities and be part of the Italian Leadership Team.

Competenze

• 8-10 years’ experience in pharmaceutical regulatory affairs.
• Knowledge of local agency regulations and industry standards.
• Ability to work in an office environment.

Mansioni

• Manage local regulatory activities for Alexion portfolio products.
• Act as official contact with local Regulatory Authorities.
• Ensure compliance with local regulations.

Conoscenze

Collaboration with regulatory agencies

Strong understanding of drug development stages

Problem-solving skills

Formazione

Pharmacist or equivalent degree in life sciences

Descrizione del lavoro

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

Local Regulatory Affairs Lead

Location: Milan, Italy

This is what you will do

This position is responsible for managing the local regulatory activities for Alexion portfolio products in Italy. The Local Regulatory Affairs Lead (RAL) will ensure full compliance with all local regulations and corporate policies and act as the official contact with the local Regulatory Authorities.

RAL is part of the Italian Leadership team and reports to the Senior Director Regulatory Affairs International.

You will be responsible for

• Being the official contact person of the Italian National Authority (AIFA)
• Being the Congress Responsible Person appointed in front of AIFA
• Providing regulatory strategy for current business and new launches
• Contributing to the Italian Leadership Team and supporting the international organization
• Submitting approval requests for Congress sponsorships
• Reviewing and submitting promotional and non-promotional materials to HA
• Managing and implementing local Risk Management Plans
• Managing labeling activities according to local requirements and internal processes
• Proofreading local labeling and packaging materials to ensure timely implementation of approved labels
• Monitoring the regulatory environment to maintain expertise and ensure internal stakeholders are informed and compliant
• Performing regulatory intelligence and sharing updates on requirements
• Interpreting regulatory requirements and translating them into actionable items
• Supporting the Scientific Service Responsible with notifications and territory coverage updates
• Partnering with pharmacovigilance and quality teams for regulatory activities and AIFA contacts
• Maintaining good regulatory practices, SOPs, and documentation in compliance with local and company standards
• Ensuring audit and inspection readiness for regulatory tasks

You will need to have

Essential Qualifications

• Pharmacist or equivalent degree in life sciences (biology, chemistry, etc.)
• 8-10 years’ experience in pharmaceutical regulatory affairs; biotech experience is a plus
• Knowledge of local agency regulations and industry standards
• Proven success in collaboration with regulatory agencies
• Strong understanding of drug development stages and regulatory processes
• Ability to work in an office environment, utilizing computers, communication tools, and problem-solving skills during standard business hours

Preferred qualifications

• Knowledge in pharmacovigilance and quality management systems is highly preferred

This job posting is active and accepting applications.