The Senior Manager, Global Regulatory Labeling Operations

Genmab seeks a Senior Manager to lead global regulatory labeling operations for EU and Rest of World markets, delivering compliant, submission-ready labeling documents and packaging components. The role provides strategic guidance on labeling requirements, oversees complex activities, and optimizes end-to-end labeling processes across markets.

Responsibilities

• Serve as regulatory labeling operations subject matter expert for EU and RoW markets, guiding requirements and resolving complex issues
• Lead planning and delivery of compliant labeling documents, patient leaflets, mockups, and artwork for regulatory submissions and product launches
• Manage EU linguistic review activities and coordinate translated labeling document approval workflows
• Oversee external vendors and partners, monitoring quality, compliance, timelines, and performance standards
• Partner with cross-functional teams to ensure effective execution of labeling activities and contribute to process improvements

Requirements

• Bachelor's degree in Life Sciences or related field, or equivalent experience
• 5+ years pharmaceutical or biotechnology industry experience with regulatory labeling focus
• Strong knowledge of EU labeling requirements and international market experience
• Working knowledge of CTD format for EU regulatory submissions
• Experience managing labeling documents, artwork, translations, and linguistic reviews
• Proficiency with electronic document and labeling management systems; Veeva experience advantageous
• Demonstrated ability to manage complex priorities, vendors, and timelines globally