Genmab · 1 day ago
Senior Director, Global Regulatory Affairs, Strategy
Princeton
Full-time
Hybrid
Director/Executive
$226K/yr - $339K/yr
15+ years expGenmab is an international biotechnology company dedicated to improving patients' lives through innovative antibody therapeutics. The Senior Director of Global Regulatory Affairs, Strategy will support Genmab's regulatory pipeline at all phases of development, providing strategic insights and leading the planning and execution of regulatory pathways to achieve regulatory approval for Genmab products.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
Providing strategic insights to global development plan based on assessment of emerging regulatory landscape and evaluation of probability of technical & regulatory success
Lead planning and execution of well-defined global regulatory pathways and executable regulatory strategies with the objective of regulatory approval as well as differentiation of Genmab products
Drive, review, and track execution of regulatory support activities by teams (e.g. regional submissions; regulatory guidance across development cycles of Genmab product portfolio; regulatory documentation; regulatory due-diligent assessment)
Guide and/or lead complex interactions with regulatory and health agencies (e.g. US FDA) on critical regulatory matters
Drive proactive relationship building and engagement with critical external stakeholders (e.g. regulatory agencies, professional societies, key opinion leaders)
Influence strategically and be an advocate and champion in external networking events
Drive engagement within team through guidance and mentorship
Accountable for budget management for own area
Qualification
Required
Minimum requirement: 15+ years of experience in relevant field
Experience with development of overall regulatory strategy across markets/regions within area, operational management of regulatory plans with cross-functional teams, as well as budget planning & management
Significant experience leading and managing regulatory processes/projects (e.g. complex submissions, maintenance of regulatory documentation, liaison and collaboration with internal cross-functional teams, external partners, and regulatory authorities)
Prior experience in building external connections with peers, regulatory communities across regions, and external network
Proven performance in earlier role/comparable role including strategic oversight and strategic stakeholder management across levels internally and externally
Experience directing teams directly/indirectly in a leadership capacity with focus on both achievement of objectives as well as critical skill-building
Preferred
Master's degree preferred
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
Company
Genmab
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
1001-5000 employees
H1B Sponsorship
Genmab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (10)
2023 (6)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$11.7BKey Investors
Morgan Stanley Senior FundingGlaxoSmithKlineIndex Ventures
2025-11-18Post Ipo Debt· $6B
2025-09-29Post Ipo Debt· $5.5B
2010-07-01Post Ipo Equity· $134M
Leadership Team
Anthony Pagano
Chief Financial Officer
Anthony Mancini
EVP & Chief Operating Officer
Recent News
Pharma Letter
2026-01-09
2026-01-09
2026-01-08
Company data provided by crunchbase