Vice President, Global Regulatory Affairs, Team Lead, Strategy

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.

Compensation (US based candidates)

$299,600.00 — $449,400.00

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