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!
To support our growing portfolio of marketed products and their ongoing lifecycle management, Genmab is seeking an Associate Director to join the Regulatory Affairs CMC team.
In this role, you will provide strategic and operational regulatory CMC expertise across the global lifecycle of our commercialized products. You will contribute to long-term lifecycle planning and global regulatory alignment, while ensuring compliant and efficient post-approval maintenance and continued commercialization worldwide.
You will join a team of 14 experienced and dedicated colleagues located in Copenhagen, Utrecht, Princeton, Tokyo, and Suzhou. The position is based in Copenhagen, Denmark, and follows a hybrid work model. We offer an exciting and challenging role in a dynamic, global company, collaborating closely across Global Regulatory Affairs and CMC.
The responsibilities of the role will include, but is not limited to:
Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle
Collaborate with cross-functional colleagues to optimize lifecycle activities and ensure alignment across functions
Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority submissions
In collaboration with CMC, plan and prepare responses to health authority information requests
Provide advice and guidance on EU, US, and selected global regulatory legislation and guidance relevant to CMC
Evaluate and communicate regulatory risks, challenges, and strategic implications across the product lifecycle
Liaise with and negotiate with global health authorities on regulatory CMC topics, representing Genmab in meetings and interactions
Stay up to date on regulatory laws, guidances, and best practices relevant to post-approval lifecycle management
Master of Science in pharmacy, engineering or equivalent
Minimum 5-10 years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics
A track record in moving therapeutic products through various stages of development
Experience with lifecycle management
Proficient communication in English (verbal and written)
Moreover, you meet the following personal requirements:
You have excellent collaboration and communication skills
You thrive being challenged and working in cross functional teams
You are able to work independently with an ability to drive projects to successful outcomes
You have a quality mindset and are able to prioritize your work in a fast paced and changing environment
You are result-oriented and committed to contributing to the overall success of Genmab
You enjoy fostering a collaborative team environment by offering support and sharing knowledge with your colleagues
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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