Associate Director, Global Regulatory Affairs, Strategy (Europe & RoW)
GenmabCopenhagen, Capital Region of Denmark, Denmark • Utrecht, Utrecht, Netherlands
Posted December 5, 2025
Full Time
About the Company
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics.
Job Description
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