Vice President, Global Regulatory Affairs, Team Lead, Strategy

Vice President, Global Regulatory Affairs Strategy

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 Genmab's 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 8–10 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 10–20%) 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: $299,600.00---$449,400.00. 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