Senior Director, Global Regulatory Affairs, Team Lead, Strategy (Europe & RoW)

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

Genmab is looking for an experienced and passionate senior leader to be a part of our Global Regulatory Affairs organization.  In this role, you will be responsible for the development of global strategies to advance Genmab’s portfolio of development pipeline candidate drugs and marketed products.  You will provide strategic input and ensure operational execution of global submission activities. You will be responsible for interfacing directly with EMA as the primary contact for programs in your portfolioand have oversight of vendors supporting ROW..

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.

The Role & Department

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.

Key responsibilities include

• Managerial/supervisory responsibilities.
• Actively mentoring of the regulatory strategists with EU/ROW responsibilities.
• 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.
• Follow all correspondence with the competent authorities across programs from EU/ROW.
• Oversee CRO quality, accountabilities and deliverables related to Regulatory activities.
• Assess EU and MHRA regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
• Interact with health authorities and lead/participate in health authority meetings.
• Present the regulatory strategy/position to senior management and health authorities, as appropriate. Interpret the communication of any health agency feedback and assess the impact on programs.
• Evaluate regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, PRIME designation, compassionate use, pediatric plans) and ensure that they are implemented, if applicable.
• Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs.
• Participate in regulatory SOP development.
• Provide input into streamlining internal RA processes.

Requirements

• 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.
• Expertise in drug development and EU regulatory mechanisms to expedite development.
• Experience within oncology is preferred.
• Prior experience leading health authority meetings with the EMA or other health authorities
• Experience with submitting and bring to completion MAAs in Europe/ROW
• Experience with variation procedures
• Strong project management skills

Moreover, you meet the following personal requirements:

• Strong organizational, communication, and time management skills needed to run multiple ongoing projects simultaneously
• Must have attention to detail and able to problem solve
• Be able to work independently with an ability to drive projects to successful outcomes
• Robust cross-functional collaboration skills and enjoy working in a global environment
• Skills in building and maintaining internal and external collaborative relationships to achieve shared goals
• Highly motivated and determined individual who enjoys being challenged
• Able to prioritize your work in a fast paced and changing environment
• Goal-oriented and committed to contributing to the overall success of Genmab

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!

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.

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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.