Associate Director, Global Regulatory Affairs, Strategy (Europe & RoW)

Genmab is seeking an Associate Director, Global Regulatory Affairs, Strategy (Europe & RoW) to lead the European/ROW regulatory strategy for assigned projects. The role involves representing Europe/ROW in the Global Regulatory Team, planning and executing clinical submission strategies, and maintaining knowledge of regulatory topics and regulations.

Requirements

• Bachelor’s degree or equivalent in scientific discipline or health-related field
• Minimum of 8 years of experience in Regulatory Affairs
• Experience in proactively planning and executing highly complex clinical submission strategies
• Prior experience leading health authority meetings with the EMA or other health authorities
• Strong project management skills
• Good understanding of drug development and European regulatory procedures