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