Nordic Regulatory Affairs Lead for Patient Access

AstraZeneca plc; Danimarca; In loco; DKK 900.000 - 1.300.000; Tempo pieno

Descrizione del lavoro

AstraZeneca Nordic Marketing Company is seeking a Regulatory Affairs professional based in Denmark to drive timely regulatory submissions, approvals, and lifecycle management across Nordic countries. You will act as the regulatory voice within brand and franchise teams, collaborating closely with Market Access, Medical, and Logistics to translate regulatory strategy into real-world patient access.

The role requires a Master's in Pharmacy or equivalent, strong regulatory experience, and fluency

Competenze

• Master's degree in Pharmacy or equivalent.
• Demonstrated experience with regulatory work.
• Experience from pharmaceutical development or manufacturing.
• Experience from working with health authorities.
• Excellent knowledge of English and at least one of the Nordic languages.
• Good knowledge of relevant legislation requirements and procedures.
• Solid business acumen and a good regulatory affairs toolbox to apply.
• Good at influencing and building relationships with senior and cross-functional stakeholders.
• Ability to plan, communicate and drive processes and projects all the way to the finish line.

Mansioni

• 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.

Conoscenze

Regulatory strategy

Regulatory submissions

Stakeholder management

English fluency

Nordic languages

Project planning

Cross-functional collaboration

Influencing

Formazione

Master's degree in Pharmacy

Descrizione del lavoro

AstraZeneca Nordic Marketing Company is seeking a Regulatory Affairs professional based in Denmark to drive timely regulatory submissions, approvals, and lifecycle management across Nordic countries. You will act as the regulatory voice within brand and franchise teams, collaborating closely with Market Access, Medical, and Logistics to translate regulatory strategy into real-world patient access.

The role requires a Master's in Pharmacy or equivalent, strong regulatory experience, and fluency