The Senior Manager Global Regulatory Labeling Operations

Job description

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. Does this inspire you and feel like a fit? Then we would love to have you join us! Role The Senior Manager, Global Regulatory Labeling Operations plays a key role in leading labeling operations for the EU and Rest of World (RoW) markets, while providing support for U.S. labeling activities. The role is responsible for the timely delivery of compliant, high-quality, submission-ready labeling documents and packaging components, including mockups and artwork, across assigned markets. As a subject matter expert in Regulatory Labeling Operations, the Senior Manager provides strategic and operational guidance on labeling requirements, oversees complex labeling activities, and works closely with cross-functional stakeholders and external partners to support regulatory submissions, product launches, and lifecycle management. The Senior Manager also contributes to the continued development and optimization of Genmab’s global end-to-end labeling processes, systems, and capabilities, helping ensure they remain efficient, scalable, compliant, and aligned with evolving regulatory requirements and industry standards. This is an individual contributor role at Senior Manager level. The role reports to the Director, Global Regulatory Labeling Operations and is based in Denmark. Responsibilities Serve as a Regulatory Labeling Operations Subject Matter Expert (SME) for EU and RoW markets, providing guidance on regulatory requirements and operational strategy, and acting as a key SME in driving the resolution of complex labeling issues and escalating significant compliance, business, or strategic risks to functional leadership. Lead the planning and delivery of compliant, high-quality, submission-ready labeling documents and packaging components, including prescribing information, patient leaflets, mockups, and artwork. Manage EU Linguistic Review activities and coordinate the review and approval of translated labeling documents. Ensure labeling deliverables meet applicable regulatory requirements and Genmab standards for quality, accuracy, consistency, and compliance. Support labeling operations for regulatory submissions, including new marketing applications and lifecycle submissions, as well as product launches and ongoing product maintenance. Oversee external vendors and partners responsible for labeling deliverables, monitoring quality, compliance, timelines, and performance and driving improvements where needed. Monitor and interpret evolving EU and RoW labeling requirements and industry standards, assess their operational impact, and communicate relevant changes to key stakeholders. Utilize labeling, artwork, and electronic document management systems to support content lifecycle management, review and approval workflows, version control, and inspection readiness. Partner closely with Regulatory Affairs, Supply Chain, Manufacturing, Quality, and other internal and external stakeholders to ensure effective planning and execution of labeling activities. Contribute to the development, implementation, and continuous improvement of global end-to-end labeling processes, tools, systems, infrastructure, SOPs, and work instructions. Identify opportunities to improve labeling processes and operational efficiency and influence implementation across functions and geographies. Represent Global Regulatory Labeling Operations in cross-functional initiatives, governance forums, and strategic discussions that impact labeling processes, systems, and capabilities. Mentor and provide guidance to junior team members, supporting knowledge sharing and capability development within the function. Requirements Bachelor’s degree in Life Sciences or a related discipline preferred, or equivalent relevant experience. 5+ years of relevant experience within the pharmaceutical or biotechnology industry, with demonstrated experience in regulatory labeling and/or regulatory operations. Strong knowledge of EU labeling requirements and experience supporting labeling activities across international or RoW markets. Working knowledge of CTD format and content for EU regulatory submissions. Experience managing labeling documents, packaging components, artwork, and/or translation and linguistic review activities. Experience working with electronic document, labeling, or artwork management systems; experience with Veeva or similar platforms is an advantage. Demonstrated ability to manage complex deliverables, priorities, vendors, and timelines in a global, cross-functional environment. Strong project and stakeholder management skills, with the ability to influence and collaborate effectively across functions and geographies. Knowledge of U.S. labeling requirements is an advantage. Excellent written and verbal communication skills in English, with strong attention to detail and a quality- and compliance-focused mindset. The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK640.000,00---960.000,00 The final salary offer will depend on several factors, including your skills, qualifications, and experience. In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to: Pension Health insurance and wellness benefits Paid time off Employee support programs Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com) .