Senior Director, Global Regulatory Affairs, Strategy

Genmab • Plainsboro Township, NJ

1d

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 Role supports Genmab's regulatory pipeline at all phases of development. Responsibilities include 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

Requirements

• Master's degree preferred 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

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

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: Director
• Number of Employees: 1,001-5,000 employees