Vice President, Global Regulatory Affairs, Team Lead, Strategy

At Genmab we are dedicated to building extranotordinary 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 Vice President Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory Affairs responsible for managing the regulatory strategy and regulatory deliverables for a portfolio of assets across all stages of development. As a strategic thought partner to the Head of Regulatory Affairs this role will influence decision-making resource planning and future initiatives while ensuring regulatory compliance and operational efficiency on a global scale.

Key Responsibilities

• Lead delivery of regulatory strategy programs in line with timelines budgets operational procedures regulations guidelines and quality standards.
• Provide global regulatory leadership; oversee development of global regulatory strategic plans in support of the global development registration and life-cycle management of products.
• Responsible for oversight and planning of meetings with health authorities.
• Engage in strategic communication with executive leadership cross-functional leadership and external stakeholder networks to optimally influence organizational outcomes.
• Monitor anticipate and adopt trends and best practices that impact regulatory to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Support Head of RA in resource planning budgeting financial reporting forecasting and process development within own department in line with strategic priorities.
• Drive a culture of continuous improvement in the department through effective regulatory plans; develop robust internal training programs for key stakeholders as needed on HA requirements.
• Ensure objectives are well communicated targets clearly defined important information cascaded and accountability driven by the Head of RA.
• Support the pipeline of talent within own team as an organizational pool investing in future skills developing coaching and challenging high potential members with different assignments.
• Team Leadership: Manage and develop a high-performing regulatory team ensuring the team is equipped to meet regulatory milestones aligned with Genmabs vision.
• Cross-functional Collaboration: Partner with internal teams and external partners to manage relationships between regulatory teams direct submissions and ensure regulatory compliance.

Education

• Advanced scientific degree required; PhD in a bioscience discipline (e.g. molecular biology pharmacology immunology biochemistry or related life sciences) or MD strongly preferred.

Required Experience

• Minimum of 15 years of progressive experience in Global Regulatory Affairs within the biotech or pharmaceutical industry with at least 810 years in roles of increasing leadership responsibility.
• Demonstrated track record of successful global regulatory submissions (IND/CTA BLA/NDA/MAA supplements and life-cycle management) across major health authorities including FDA EMA PMDA and Health Canada.
• Extensive experience leading and interacting with health authorities including successful execution of Type A/B/C meetings Scientific Advice End-of-Phase meetings Pre-BLA/NDA meetings and Advisory Committee preparations.
• Significant experience in oncology immunology or other complex therapeutic areas (biologics antibody-drug conjugates bispecifics or novel modalities preferred).
• Deep expertise across the full product lifecycle from early development through late-stage clinical registration launch and post-marketing.
• Proven experience leading regulatory strategy for partnered or co-developed programs including negotiation with collaboration partners.
• Demonstrated success building leading and scaling high-performing global regulatory teams across multiple geographies.
• Experience representing Regulatory Affairs at the executive level Governance Committees as required.

Technical Skills and Regulatory Knowledge

• Comprehensive knowledge of global regulatory frameworks including FDA (21 CFR) EMA (EU CTR EU MDR where applicable) ICH guidelines and emerging markets regulations.
• Expertise in expedited regulatory pathways (Breakthrough Therapy Fast Track Priority Review Accelerated Approval PRIME Orphan Drug Designation).
• Strong understanding of CMC regulatory requirements nonclinical and clinical regulatory expectations pharmacovigilance labeling advertising/promotion and post-marketing commitments.
• Working knowledge of companion diagnostics (CDx) co-development and combination product regulations where relevant.
• Familiarity with regulatory information management systems eCTD publishing and digital submission platforms.
• Ability to interpret emerging regulatory guidance policy and legislation and translate implications into actionable strategy.

Leadership Competencies and Soft Skills

• Strategic thinker with the ability to translate regulatory science into actionable commercial and development strategy.
• Exceptional executive presence and communication skills; able to influence and align stakeholders at all levels from technical teams to C-suite and Board.
• Demonstrated ability to navigate complex matrixed global organizations and drive alignment across R&D Clinical CMC Commercial Legal and Medical Affairs.
• Strong decision-making skills under uncertainty; comfortable balancing scientific rigor regulatory risk and business priorities.
• Inspirational people leader with a strong track record of coaching mentoring and developing talent.
• Cultural awareness and experience working across geographies particularly across US EU and Asia-Pacific regions.
• High integrity resilience and the ability to thrive in a fast-paced science-driven biotech environment.
• Collaborative mindset with a bias for action and continuous improvement.

Working Conditions and Travel

• This role offers flexibility to work away from the office for 20%40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days provided it does not exceed 40% within a 60-day period and is approved by the hiring manager.
• Domestic and international travel expected (approximately 1020%) for health authority meetings site visits conferences and team/partner engagements.

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

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 youre 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.