Senior Director, Global Regulatory Affairs, Team Lead for Affiliate Regulatory 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!

Role and Department

As Senior Director, you will join our Global Regulatory Affairs organization and lead the group of Regulatory Liaisons that represent regulatory at Genmab Affiliates located in Europe, Asia-Pacific (APAC) and Latin America (LATAM). The goal is to ensure optimal in-country regulatory support to implement an integrated global regulatory strategy and meet local regulatory needs to commercialize novel oncology products.

You will manage and mentor the Regulatory Liaisons and act as the senior regulatory partner to our Affiliates with oversight of regional regulatory vendors. You will be providing business input for the development of SOPs and regulatory systems and documentation needed to execute and maintain regional marketing authorizations.

The position is based in our Utrecht office and follows a hybrid work model. It reports to the Head of Global Regulatory Affairs.

Responsibilities

Key responsibilities include, but are not limited to:

• Provide managerial and supervisory leadership to the Regulatory Liaisons with local European member state, APAC and LATAM responsibilities, including active mentoring, objective setting, resource allocation and talent development.

• Oversee the development and execution of regional regulatory strategies, including pathway selection, use of expedited and reliance mechanisms, and submission sequencing.

• Act as the senior regulatory contact for Affiliate leadership and local regulatory teams, ensuring Affiliates have the guidance and support to execute submissions, variations, renewals and post-approval commitments.

• Proactively evaluate and communicate regulatory risks and challenges, and mitigation options, to senior management in a timely manner.

• Assess regional regulatory guidelines, regulations and the current regulatory environment, and their impact on the development and lifecycle of Genmab products.

• Interact with local health authorities and lead or participate in health authority meetings.

• Oversee regional submission timelines, regulatory fee forecasting and budgets, and manage external regulatory partners and consultancies where applicable.

• Partner with Global Regulatory Leads, Clinical Development, CMC, Drug Safety & Pharmacovigilance, Clinical Operations, Quality, Market Access and Commercial to integrate regional requirements into global development plans.

• Represent Regulatory Affairs across Genmab committees as indicated.

• Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs.

• Participate in regulatory SOP development and provide input into streamlining internal RA processes.

• Contribute as a key member of the Regulatory Affairs leadership team.

Requirements

• Graduate level degree, preferably within the life sciences (PharmD, PhD or MD preferred).

• Minimum of 12 years of experience within Regulatory Affairs, including significant experience leading people and/or managers (oncology experience preferred).

• Direct interaction and negotiation skills with regulatory authorities (e.g. European National Health Authorities, and APAC and LATAM authorities).

• Proven track record in marketing authorization applications and approvals in Rest of World markets, including APAC and/or LATAM.

• Broad knowledge of development and lifecycle management.

• Experience working with affiliates and managing regional regulatory budgets, timelines and external partners.

• Strong leadership, mentoring and cross-functional collaboration skills in a global, matrixed environment.

• Excellent communication skills in English, both verbal and written. Additional languages are an advantage.

• Cultural awareness and respect for diversity.

• Ethics, professional integrity and personal values consistent with the Genmab values.

The proposed gross annual base salary range for this position, in the primary location, based on a full time schedule is:
EUR115.200,00---172.800,00

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.

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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.