Associate Director, Global Regulatory Affairs, Strategy (Europe and 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 Associate Director, Regulatory Lead, Europe and Rest of World (RoW), to join our Global Regulatory Affairs organization in Utrecht, the Netherlands. In this role, you will lead the development and execution of the European and RoW regulatory strategy for one or more compounds across Phase I to Phase III development. You will represent the European and RoW perspective within Global Regulatory Teams and provide regulatory guidance to cross-functional development teams.

You will join at an important stage for our portfolio, with significant regulatory submissions ahead. This is a hands-on role for someone who combines strong scientific understanding with regulatory expertise and is comfortable taking direct ownership of both strategy and execution. You will proactively evaluate and communicate regulatory risks and challenges and relevant mitigatory actions, to senior leadership and project teams.

You will also provide regulatory guidance to Clinical Trial Teams, working closely with internal stakeholders and external partners to maintain oversight and progress of clinical trial submissions across Europe and RoW.

Responsibilities

• Develop and execute the European and RoW regulatory strategy for one or more assigned development programs.

• Represent Europe and RoW within Global Regulatory Teams and provide clear regulatory recommendations to Compound Development Teams and other cross-functional stakeholders.

• Lead the European and RoW contribution to major regulatory submissions and ensure that regional requirements are reflected in global filing plans.

• Lead the preparation of strategic regulatory documentation for interactions with the European Medicines Agency and national health authorities, such as scientific advices, Paediatric Investigation Plans, and orphan drug designation applications.

• Proactively identify and evaluate regulatory risks, propose practical mitigation strategies, and communicate their potential impact to cross-functional teams and management.

• Represent Regulatory Affairs within Clinical Trial Teams and oversee the planning and execution of complex clinical trial submissions.

• Work closely with CROs and internal stakeholders to ensure the quality, consistency, and timely progress of regulatory activities.

• Monitor changes in the European and international regulatory environment and assess their potential impact on Genmab’s development programs.

• Contribute to the continuous improvement of regulatory processes, tools, and ways of working.

Requirements

• An advanced degree in a relevant scientific, medical, pharmaceutical, or health-related discipline. A PhD or equivalent depth of scientific expertise is an advantage.

• At least six years of experience within the pharmaceutical or biotechnology industry, preferably covering clinical development through marketing authorization application.

• Experience developing and executing regulatory strategies for complex clinical development programs.

• Demonstrated experience preparing for and leading interactions with the EMA or national health authorities.

• Strong understanding of drug development and European regulatory procedures.

• The ability to critically assess scientific and clinical data and translate it into clear regulatory strategies and positions.

• Experience overseeing complex clinical trial submission activities, including collaboration with CROs and cross-functional teams.

• Experience in oncology and/or the development of biologics is an advantage.

• Experience with Paediatric Investigation Plans is an advantage.

• Strong planning and project management skills, with the ability to manage multiple priorities and deadlines.

• A proactive and hands-on approach, with the willingness to take ownership of both strategic and operational regulatory activities.

• Strong judgment and problem-solving skills, with the ability to work independently and escalate appropriately.

• Clear and persuasive communication skills and the ability to build trusted relationships across functions, geographies, and levels of seniority.

• A collaborative mindset and the flexibility to work effectively in a fast-moving, global environment.

Intended Recruitment Timeline

• Application deadline: Thursday 11 September (end of day).

• Virtual screenings: week of 14 September.

• Onsite interviews: last two weeks of September.

• Intended start date: 1 Nov.

The proposed gross annual/monthly base salary range for this position, in the primary location, based on a full time schedule is:

EUR76.000,00---114.000,00


The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

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 contract.