Vice President, Global Regulatory Affairs, Team Lead, Strategy

Genmab • Princeton, TX

1d • Hybrid

About The Position

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.
• 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.
• 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

• PhD in a bioscience discipline (e.g., molecular biology, pharmacology, immunology, biochemistry, or related life sciences) or MD strongly preferred.
• Experience in biologics, antibody-drug conjugates, bispecifics, or novel modalities preferred.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 501-1,000 employees