Description

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 supports Genmab's regulatory pipeline at all phases of development. Responsibilities include providing strategic insights to global development plan based on assessment of emerging regulatory landscape and evaluation of probability of technical & regulatory success; Lead planning and execution of well-defined global regulatory pathways and executable regulatory strategies with the objective of regulatory approval as well as differentiation of Genmab products; Drive, review, and track execution of regulatory support activities by teams (e.g. regional submissions; regulatory guidance across development cycles of Genmab product portfolio; regulatory documentation; regulatory due-diligent assessment); Guide and/or lead complex interactions with regulatory and health agencies (e.g. US FDA) on critical regulatory matters; Drive proactive relationship building and engagement with critical external stakeholders (e.g. regulatory agencies, professional societies, key opinion leaders); Influence strategically and be an advocate and champion in external networking events Drive engagement within team through guidance and mentorship; Accountable for budget management for own area

Requirements: Master's degree preferred Minimum requirement: 15+ years of experience in relevant field. Experience with development of overall regulatory strategy across markets/regions within area, operational management of regulatory plans with cross-functional teams, as well as budget planning & management. Significant experience leading and managing regulatory processes/projects (e.g. complex submissions, maintenance of regulatory documentation, liaison and collaboration with internal cross-functional teams, external partners, and regulatory authorities). Prior experience in building external connections with peers, regulatory communities across regions, and external network. Proven performance in earlier role/comparable role including strategic oversight and strategic stakeholder management across levels internally and externally. Experience directing teams directly/indirectly in a leadership capacity with focus on both achievement of objectives as well as critical skill-building.

For US based candidates, the proposed salary band for this position is as follows:

$226,080.00---$339,120.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 401(k) Plan: 100% match on the first 6% of contributions
  
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
  
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
  
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
  
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
  
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
  

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.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

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.