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.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

The Director is responsible for leading or overseeing the timely delivery of compliant, high-quality submission-ready global/local labeling documents and packaging component mockups/artworks for the EU Centralized Procedure (CP), US Market and local market efforts. This role provides management and oversight of vendors and local regulatory labeling consultant contributions and ensures alignment of local market labeling deliverables with broader regulatory and business objectives. The Director is also responsible for supporting regulatory intelligence deliverables related to global labeling activities and expertise. The candidate brings expertise in global labeling requirements and industry best practices, demonstrated cross-functional leadership and strong strategic planning capabilities.   

Responsibilities

• 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.

Qualifications

• 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.

For US based candidates, the proposed salary band for this position is as follows:

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. 

When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 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 

About You

• 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!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

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).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.