Associate Director, Global Regulatory Affairs, Labeling

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 RoleThe Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance of global labeling documents (e.g., Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, Policy and Intelligence.Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.ResponsibilitiesLead the Labeling Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents.Serve as the labeling subject matter expert responsible for advising teams on global labeling strategies based on Genmab’s development programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead, supporting development, approval and maintenance of regional labeling (e.g., JPI)Manage new projects and projects of increased complexity including those involving 3rd party collaboratorsKeep up to date with global labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordinglyAdvise LWG on the content of labels in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling.Ensure proper development, review, approval, implementation, maintenance, distribution and tracking of labeling documents according to internal SOPs and external regulatory requirements.Prepare submission-ready labeling documents; Maintain and track labeling documents in the electronic system as appropriate.Participate in the development and maintenance of SOPs, work instructions, templates, and associated documentsThis position may also support regulatory policy and/or intelligence deliverables:Monitor the regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.Manage process for dissemination of regulatory intelligence and subsequent impact assessment within GenmabWork closely with the global regulatory leads (GRLs), regional regulatory leads (RRLs) and global labeling leads (GLL) to support ad-hoc queries, providing novel insights to inform the regulatory strategies for development or marketed products.Support policy deliverables, e.g., call for comments effortsRequirementsBachelor’s degree in a scientific discipline is required; PharmD/PhD preferred.3-5 years of pharmaceutical industry experience preferred, including 2-3 years Labeling (preferred) or related experienceIn-depth knowledge of current US and global regulations and guidance, especially as they relate to global labelingUnderstanding of clinical development of novel biologics products, preferably in oncologyExperience developing and managing labeling content for at least one major submission (e.g., NDA/BLA), through negotiations and approval preferredFamiliar with end-to-end labeling processesAbility to critically distinguish between “noise” and meaningful news to key stakeholders and senior leadersAbility to think strategically, communicate risks, and recommend course of actionSelf-starter with superior time management skills, ability to balance multiple tasks to meet priorities and timelinesAbility to work independently or in teams. Ability to lead broad range of stakeholders at all levels internal and external to the companyStrong attention to detailEffective communication skills, specifically excellent oral and written presentation skills.Strong sensitivity for a multicultural/multinational environmentProficiency with MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for this position is as follows:$174,320.00---$261,480.00The 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 contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About YouYou are genuinely passionate about our purposeYou bring precision and excellence to all that you doYou believe in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with a broad spectrum of backgroundsYou take pride in enabling the best work of others on the teamYou can grapple with the unknown and be innovativeYou 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!LocationsGenmab 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 GenmabGenmab 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.

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