Manager, Global Regulatory Affairs, Strategy

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 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:

The responsibilities of the role will include, but is not limited to:

• 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 mind set and 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-