Vice President, Global Regulatory Affairs, Team Lead, Strategy

Genmab•Princeton, FL

18h•Hybrid

About The Position

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 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.

Requirements

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

Nice To Haves

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!

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.
Manage and develop a high-performing regulatory team, ensuring the team is equipped to meet regulatory milestones aligned with Genmab’s vision.
Partner with internal teams and external partners to manage relationships between regulatory teams, direct submissions, and ensure regulatory compliance.

Benefits

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

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