Local Regulatory Affairs Lead, Milano, Italy

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
• 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 “country” regulations and corporate policies and act as the official contact (authorized regulatory person) with the local Regulatory Authorities.

RAL is part of the Italian Leadership team and reports to the Senior Director Regulatory Affairs International. The position is based in Milan.

• You will be responsible for

This position contains tasks related to regulatory management areas. Tasks may change over time across and within the respective areas depending on Alexion business needs.

• Be the official contact person of the Italian National Authority (AIFA)
• Be the Congress Responsible Person appointed in front of AIFA
• Provide regulatory strategy for current business and / or new launches
• Actively contribute to the Italian Leadership Team and ensure supporting and contribution to the international organization
• Submission for approval of Congresses' sponsorship
• Review and submit to HA promotional and non-promotional materials
• Management and local implementation of Risk Management Plan (Local Implementation Plan review and approval, education materials, certificate of vaccinations)
• Manage all labeling activities as per local requirements and internal Alexion processes for all products.
• Conduct proof reading of all local labelling and packaging materials to ensure final approved labeling for all locally approved products are implemented timely
• Continually monitors the regulatory environment to maintain expertise in regulatory principles, new issues, competitive products, and implications
• monitoring the external regulatory environment and ensuring internal stakeholders’ awareness and implementation of local requirements accordingly
• Performs regulatory intelligence and share information on regulatory requirements and ensure the local implementation
• Ability to understand and interpret regulatory requirements and translate this into concrete propositions.
• Support the Scientific Service Responsible (Notifying RAM sales call and any change in the territory coverage)
• Partner with local pharmacovigilance and quality responsibles, in regulatory activities and contacts to AIFA.
• Ensure maintenance of good regulatory affairs practices in terms of local RA SOPs, procedures, and good documentation practices as per local requirement and Alexion processes.
• Ensure audit and inspection readiness for all regulatory affairs tasks and documentations in collaboration with local QA and PV Leads.
• You will need to have

Definition

• Essential Qualifications
• The minimum skills and requirements needed for the position)
• Pharmacist or equivalent education in a life science (biology, chemistry, etc.)
• 8-10 years’ experience in the pharmaceutical industry as regulatory affairs is a requirement, biotech is a plus
• Working knowledge of the local Agency regulations and industry standards pertaining to regulatory is essential
• Proven track record of effective collaboration with local agency in gaining approvals and defending approved products.
• Strong knowledge of local regulatory environment and excellent understanding of all stages of drug development, including pre-approval and marketed compounds.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to : use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• We would prefer for you to have
• Knowledge in pharmacovigilance and quality management system is highly preferred.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.