Manager, Global Regulatory Affairs, Strategy

At Genmab, we are dedicated to building extraordinary 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 a Regulatory Manager to be a part of our Global Regulatory Affairs (GRA) organization.

In this role, the candidate will support the Global Regulatory Lead and/or Regional Regulatory Lead in the preparation of regulatory documentation and submissions to health authorities. The candidate will work in close collaboration with the Global Regulatory Lead and/or Regional Regulatory Lead for US.

The position is based in Copenhagen and is a hybrid role.

Responsibilities:

• Support the Global/Regional Regulatory Lead with preparation of regulatory documents, e.g. meeting requests, briefing documents, orphan drug designations, breakthrough therapy designation requests, response documents, module 1 documents etc.
• In collaboration with the Global/Regional Regulatory Lead, prepare or oversee preparation of regulatory submissions to health authorities, including management and oversight of timely input and delivery of documentation to meet deadlines for regulatory submissions.
• In collaboration with the Global/Regional Regulatory lead, evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
• Support Global/Regional Regulatory Lead to assess global and US regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
• Follow all correspondence with the health authorities and ensure archiving and tracking.
• Proactively and in a timely manner, evaluate and communicate to the project team and management regulatory risks and challenges, and propose ways of mitigation.
• Maintain an updated knowledge of regulatory topics and regulations and provide regulatory input and recommendations to the project team and management.
• Support the Global/Regional Regulatory Lead with preparations for health authority meetings and participate in health authority meetings, as applicable.
• Maintenance/operational regulatory work such as compiling and submission of amendments, DSURs and IB updates.

Requirements:

• A minimum of bachelor's degree or equivalent in scientific discipline or health-related field.
• Minimum of 3 years of experience in Regulatory Affairs.
• Experience in coordination of support to regulatory activities.
• Experience maintaining and tracking critical regulatory documentation in EDMS.

Moreover, you meet the following personal requirements:

• Organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must have attention to detail and be able to solve problems with some supervision.
• Demonstrate robust teamwork by providing support with troubleshooting and resolving issues that arise within submission activities.
• You have a quality mindset and are able to prioritize your work in a fast-paced and changing environment.
• You are result- and 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

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.

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