Senior Global Regulatory Labeling Lead (EU & RoW)

Genmab; København; On-site; DKK 640,000 - 960,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab is seeking a Senior Manager, Global Regulatory Labeling Operations based in Denmark. You will lead EU and RoW labeling activities, support US labeling, and guide cross‑functional teams to deliver compliant labeling documents and artwork.

In this senior individual contributor role, you will optimize end‑to‑end labeling processes, manage vendors, coordinate translations, and ensure alignment with evolving regulatory requirements while advancing lifecycle submissions and product launches.

Qualifications

• Bachelor’s degree in Life Sciences or related field preferred, or equivalent experience.
• 5+ years in pharma/biotech with regulatory labeling/or operations experience.
• Strong knowledge of EU labeling requirements and RoW support.
• Experience with EU CTD format and regulatory submissions.
• Experience managing labeling documents, artwork and translations.
• Experience with electronic document management systems; Veeva is an advantage.
• Ability to manage complex deliverables with global stakeholders.

Responsibilities

• Serve as SME for EU and RoW labeling requirements and strategy.
• Lead planning and delivery of compliant labeling documents and packaging components.
• Manage EU Linguistic Review and translation coordination.
• Ensure labeling deliverables meet regulatory standards and Genmab policies.
• Support regulatory submissions, lifecycle submissions, and launches.
• Oversee external vendors for labeling deliverables and monitor performance.
• Monitor evolving labeling requirements and communicate changes.
• Use labeling and artwork systems to support lifecycle management.
• Collaborate with Regulatory Affairs, Supply Chain, Manufacturing, Quality and others.
• Contribute to end-to-end labeling process improvements and SOPs.
• Identify opportunities to improve efficiency across functions.
• Represent Global Regulatory Labeling Operations in cross-functional initiatives.
• Mentor junior team members and support capability development.

Skills

EU labeling experience

Regulatory labeling

Project management

Cross-functional collaboration

English communication

CTD knowledge

Veeva familiarity

Education

Bachelor’s degree in Life Sciences

Tools

Veeva

Job description

Genmab is seeking a Senior Manager, Global Regulatory Labeling Operations based in Denmark. You will lead EU and RoW labeling activities, support US labeling, and guide cross‑functional teams to deliver compliant labeling documents and artwork.

In this senior individual contributor role, you will optimize end‑to‑end labeling processes, manage vendors, coordinate translations, and ensure alignment with evolving regulatory requirements while advancing lifecycle submissions and product launches.