Nordic Regulatory Affairs Associate Labelling Submissions

AstraZeneca plc; København; Hybrid; DKK 650,000 - 900,000; Full time

Job summary

AstraZeneca Nordic Marketing Company is seeking a Regulatory Affairs professional to oversee Nordic artwork, labelling, and submissions to ensure compliant, timely access to medicines.

You will collaborate with Nordic and global teams, manage lifecycle changes, engage with authorities, and drive process improvements. This maternity cover is a fixed term contract ending in March 2028 and requires on-site presence three days per week in Nordic offices.

Qualifications

• University degree in Pharmacy or equivalent.
• Experience in pharmaceutical regulatory work.
• Excellent knowledge of English and Nordic languages.

Responsibilities

• Artwork and Labelling Leadership (Gazelle): manage artwork projects to standards and approve accuracy for supply.
• Launch and Lifecycle Management: prepare regulatory submissions for timely approvals and market supply.
• Regulatory Intelligence and Adaptation: monitor changes in labelling regulations and translate into updates.
• Authority Engagement: communicate with health authorities on pending issues and evolving requirements.
• Cross-Functional Collaboration: align plans with internal and external stakeholders.
• Data Integrity and Documentation: record submission lifecycle and maintain archives.
• SOP Ownership and Compliance: update SOPs and ensure compliance; deliver right-first-time outputs.
• Team Contribution: drive improvements and share best practices.

Skills

Regulatory submissions

Regulatory intelligence

Stakeholder engagement

Project planning

Education

University degree in Pharmacy

Tools

Gazelle system

Job description

AstraZeneca Nordic Marketing Company is seeking a Regulatory Affairs professional to oversee Nordic artwork, labelling, and submissions to ensure compliant, timely access to medicines.

You will collaborate with Nordic and global teams, manage lifecycle changes, engage with authorities, and drive process improvements. This maternity cover is a fixed term contract ending in March 2028 and requires on-site presence three days per week in Nordic offices.