Senior Director, Global Regulatory Affairs, Strategy

Role Overview

Lead global regulatory strategy for all phases of Genmab’s development pipeline, ensuring alignment with emerging regulatory landscapes and enabling swift, differentiated product approvals.

Responsibilities

• Provide strategic insights to the global development plan based on assessment of the emerging regulatory landscape.
• Lead planning and execution of well‑defined global regulatory pathways and executable strategies.
• Drive, review, and track execution of regulatory support activities by cross‑functional teams.
• Guide and/or lead complex interactions with regulatory and health agencies (e.g., US FDA).
• Build proactive relationships with external stakeholders, including regulatory agencies, professional societies, and key opinion leaders.
• Advocate and champion Genmab’s products at external networking events.
• Drive engagement within the team through mentorship and guidance.
• Accountable for budget management of the regulatory planning area.

Qualifications

• Master’s degree preferred; Bachelor’s degree acceptable with sufficient experience.
• 15+ years of experience in regulatory strategy development across multiple markets/regions.
• Demonstrated experience in operational management of regulatory plans with cross‑functional teams.
• Extensive experience leading regulatory projects, including complex submissions, regulatory documentation, and liaison with external partners.
• Proven track record of building external connections with regulatory communities worldwide.
• Strategic oversight and stakeholder management across internal and external levels.
• Leadership experience directing teams (directly or indirectly) with a focus on objective achievement and skill development.

Salary

$226,080.00 — $339,120.00 (US‑based candidates)

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

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 operates an agile, hybrid work environment with open, community‑based office spaces in North America, Europe, and Asia Pacific. Whether in‑office or remote, we thrive on connecting through technology and collaborative culture.

About Genmab

Genmab is an international biotechnology company dedicated to improving patient lives through innovative, differentiated antibody therapeutics. Since 1999, we have pioneered next‑generation antibody platforms and are driven by a vision to transform care with Knock‑Your‑Socks‑Off (KYSO®) antibody medicines.