Senior Director, Regulatory Affairs EU

Updated: April 30, 2024 04:58 PM GMT

10001056 - Director Regulatory

Barcelona

This role is the key account manager for the regulatory EU Marketing Company (EUMC) thereby managing and coordinating all EU regulatory affairs CP-related matters in close collaboration with local EU Marketing Company Regulatory Affairs (MCRA) Heads, EU marketing company presidents and all relevant Global Functions.

Internal Focus:
• Responsible for EUMC legal accountabilities are met.
• Leads the EU Regulatory Coordination Team (EU RCoT)
• Works with local EU MCRA Heads and Global Functions to define, support and deliver the overall EU regulatory strategy and workplan with appropriate resourcing at local level.
• Ensures EU specific regulatory legislation are fully embedded in the overall AZ organization.
• Is the main link into the global regulatory Therapeutic Area (TA) organizations ensuring aligned ways of working and consistent and timely communication from and towards EU MCRA is delivered for centralized registered products.
• Ensures that the regulatory operating model and... More Detail