Lead Compliance Manager

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. De volgende informatie geeft een overzicht van de vaardigheden, kwaliteiten en kwalificaties die nodig zijn voor deze functie. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. Genmab is looking for an experienced and passionate senior leader to be a part of our Global Regulatory Affairs organization. In addition, as a Senior Director you will be leading and mentoring the group of dedicated Regulatory Strategists with Europe/Rest of World (ROW) responsibilities for Genmab’s assets across all stages of development. As a Senior Director, you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the Europe/ROW regulatory strategy for an assigned portfolio and will manage a group of Regulatory Strategists with Europe/ROW responsibilities for our programs across all stages of development. As the senior leader you may act as the deputy for the Head of Regulatory Affairs on Labeling Review Committees, Protocol Review Committees, and Audit/Inspection Committees. The ultimate goal is to ensure an optimal development and implementation of an Europe/ROW regulatory strategy for Genmab’s programs that enables an integrated global clinical development and commercial strategy. This position will report to the Head of Regulatory Affairs. Develop global regulatory strategies for the assigned projects through integration of regional regulatory strategies and in line with the global development and commercial goals. Lead or be responsible for the planning and implementation of regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions, CMC changes, PIPs). Represent Regulatory Affairs across Genmab committees as indicated. Proactively and in a timely manner, evaluate and communicate to senior management regulatory risks and challenges, and mitigation options. Oversee CRO quality, accountabilities and deliverables related to Regulatory activities. Interact with health authorities and lead/participate in health authority meetings. Present the regulatory strategy/position to senior management and health authorities, as appropriate. Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs. A minimum of Bachelor’s degree or equivalent in scientific discipline or health-related field. PhD or MD degree will be preferred. Minimum of 10 years of experience in Regulatory Affairs, across all development phase Significant experience in proactively planning and implementing highly complex clinical submission strategies Experience in leading a team of regulatory strategist professionals. Prior experience leading health authority meetings with the EMA or other health authorities Strong project management skills Strong organizational, communication, and time management skills needed to run multiple ongoing projects simultaneously 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 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. 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. xbpjoel 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.