Senior Manager, Regulatory Affairs, EU Regulatory Affiliate Liaison

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 and Department

We are looking for a Senior Manager, Regulatory Affairs, EU Affiliate Liaison to join our Global Regulatory Affairs organization and help bring medicines to patients across Europe.

Working alongside the Director, Regulatory Affairs, EU Affiliate Liaison, you will be the day-to-day regulatory partner to a defined group of EU affiliates, ensuring the national regulatory deliverables after centralized EU approval are planned, executed, and compliant. You will report to the Director, Regulatory Affairs, EU Affiliate Liaison. The position is based in Utrecht, the Netherlands.

You will own the operational detail of national launch readiness: tracking member state requirements, coordinating local service providers, preparing national health authority interactions, and keeping affiliates informed of post-approval changes that affect product availability. You will be the person who knows the status of every country in your remit and makes sure nothing falls through the cracks on the path from EC approval to patients.

The role is an onsite role In Utrecht, reporting to the Senior Director, Affiliate Team Lead.

Responsibilities

• Manage national requirements following EC approval and escalate strategic or cross-market issues to the Director
• Build and maintain country-level launch readiness trackers covering national regulatory deliverables, timelines, dependencies, and risks for new products and major label expansions

• Track EMA and national competent authority post-approval commitments and obligations across your markets and work with affiliates to ensure timely and compliant implementation

• Prepare and coordinate national health authority interactions, including drafting responses to authority queries, assembling briefing materials, and following up on commitments with affiliate colleagues and local service providers

• Manage day-to-day relationships with local regulatory service providers, including scope definition, quality oversight, and deliverable tracking, and flag performance or budget concerns to the Director

• Support affiliates during inspections, product availability or supply constraints, and other urgent national regulatory matters, acting as the link to Global Regulatory and other global functions

• Monitor changes in national regulatory requirements across your markets, assess their impact, and communicate practical implications to affiliate and global teams

• Draft and maintain SOPs, work instructions, templates, and country requirement guides that support consistent, compliant ways of working across the EU affiliate network

• Prepare status reports and regulatory input for EU Commercial Leadership Team and Global Regulatory Team meetings on behalf of the Director

Requirements

• A university degree in a scientific or health-related field; a graduate degree (preferred)

• At least 3 years of Regulatory Affairs experience in the EU, including hands-on experience with national requirements for commercialization and post-approval activities in multiple member states

• Experience in a regulatory affiliate role or in a regional/global role supporting EU affiliates

• A solid understanding of ICH guidelines, the EU centralized procedure, and national requirements for product launch and lifecycle maintenance

• Experience coordinating with national competent authorities and managing regulatory service providers

• Strong project management skills with demonstrated ability to track and deliver multiple parallel workstreams

• Excellent verbal and written communication skills in English; additional European languages (a plus)

• Experience in oncology (a plus)

As a person you bring following

• You are organized and detail-oriented, and take ownership of outcomes across multiple markets at once

• You anticipate problems and resolve them with minimal supervision, knowing when to escalate

• You build trusted relationships with affiliate colleagues, service providers, and global team members

• You translate regulatory requirements into clear, practical guidance for commercial and operational audiences

• You communicate proactively and keep stakeholders informed without being asked

• You thrive in a global, cross-functional environment and enjoy working collaboratively

• You adapt quickly and prioritize with confidence in a fast-paced, changing environment

• You are motivated by seeing patients gain access to new medicines and committed to Genmab's overall success

The proposed gross annual base salary range for this position, in the primary location, based on a full time schedule is:
EUR68.000,00---102.000,00

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.