Regulatory Affairs Manager (Denmark) - Nordic Marketing Company

Are you ready to shape patient access across the Nordics by turning science into approved, available medicines? Do you thrive in complexity, navigating multiple indications and evolving legislation to find clear paths to approval? _Then this could be your next step with us at AstraZeneca!
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Our AstraZeneca Nordic Marketing Company employs around 550 people and has offices located in Copenhagen, Stockholm, Oslo, and Espoo. AstraZeneca Nordic is a recognized leader in its core therapy areas and aims to improve the lives of millions of people. This is an area where you are free to grow - you are encouraged to challenge traditional ways of working and exercise your curiosity. We drive innovative science, deliver key launches, build close collaboration and partnerships within health care.

Introduction to role:

In this Denmark-based role covering all Nordic countries, you will drive timely management of regulatory submissions and approvals, successful launches, and seamless lifecycle management to facilitate earlier access and safer use of our medicines. You will act as the regulatory affairs voice within brand and franchise teams, partnering closely with Market Access, Medical, Logistics, and others to connect regulatory strategy to real-world outcomes for patients and the business.

You will collaborate with European and global regulatory colleagues to influence plans with local insights, while being empowered to work independently and make decisions at pace to align science, policy, and patient need.

Accountabilities:

• Regulatory Strategy and Execution: Lead regulatory activities across launched products and pipeline assets to secure rapid, high-quality approvals and timely patient access.
• Intelligence and Foresight: Monitor changes in legislation and competitive activity to turn insights into advice, risk mitigation, and opportunities that shape plans and timelines.
• Authority Engagement: Build and maintain productive relationships with national health authorities; manage communications on pending issues and evolving requirements to de-risk regulatory approvals.
• Global Collaboration: Keep European and global regulatory teams current on local requirements and external dynamics; influence global strategies with Nordic perspectives.
• Compliance and Quality: Ensure labelling and compendial texts meet external requirements and AstraZeneca policies.
• Team Contribution: Drive ways-of-working improvements, contribute to department development, and share best practices that raise team effectiveness.