Director - Global Labeling, Policy, and Intelligence Operations

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

• Lead the delivery of compliant, submission-ready labeling documents, including prescribing information, patient leaflets, and packaging mockups/artwork for US and EU CP. Oversee external vendors and local regulatory consultants' delivery of timely, compliant labeling in support of local markets and product maintenance.
• Partner with Regulatory, Commercial, Supply Chain, Quality, other internal stakeholders and external consultants/vendors to lead (US, EU CP), or provide oversight of local mockup/artwork development and submission/launch readiness activities.
• Support the development and continuous improvement of global end-to-end (E2E) labeling processes, tools, and systems and infrastructure. Provide guidance on global labeling requirements and evolving industry standards.
• Develop/maintain processes to support robust RIM document control, lifecycle management and tracking for global and local labeling documents in accordance with industry best practices.
• Manage vendor delivery of EU CP translations (including linguistic reviews), U.S. Structured Product Labeling (SPL), and other market specific labeling submission deliverables.
• Lead or oversee development of market-specific labeling processes and ways of working e.g., WIs/SOPs, templates
• Manage vendor relationships, not limited to contract development and execution, training & onboarding, budget planning
• Contribute labeling input to PSURs, Annual Reports, and other periodic regulatory reports.
• Support Regulatory Intelligence deliverables related to global labeling activities and expertise. Lead forward-looking projects related to global labeling implementation and compliance initiatives, e.g., electronic labeling
• Ensure all activities comply with internal SOPs, global regulatory requirements, and GxP standards.

• Bachelor's degree in Science, Business, or a related field.
• Minimum of 8 years' experience in Regulatory Labeling Operations, or related role within the pharmaceutical or biotechnology industry.
• Expertise in global labeling regulations, processes and systems.
• Strong strategic planning capabilities and demonstrated leadership in a global, cross-functional environment. Experience in overseeing delivery of labeling contributions to time and quality is desired.
• Effective communicator with strong negotiation and stakeholder engagement capabilities.
• Excellent organizational, project management, and change management skills.
• Deep understanding of the regulatory, quality, and supply chain implications of labeling and non-compliance.

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!