Senior Director, Global Regulatory Affairs, Team Lead, Strategy (Europe & RoW)
GenmabCopenhagen, Capital Region of Denmark, Denmark • Utrecht, Utrecht, Netherlands
Posted December 4, 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 a Senior Director, Global Regulatory Affairs, Team Lead, Strategy (Europe & RoW) to develop global strategies to advance Genmab’s portfolio of development pipeline candidate drugs and marketed products.
Requirements
- Minimum of 10 years of experience in Regulatory Affairs
- Significant experience in proactively planning and implementing highly complex clinical submission strategies
- Experience in leading a team of regulatory strategist professionals
- Expertise in drug development and EU regulatory mechanisms to expedite development
- Prior experience leading health authority meetings with the EMA or other health authorities
- Experience with submitting and bringing to completion MAAs in Europe/ROW
- Experience with variation procedures
- Strong project management skills
- Strong organizational, communication, and time management skills
- Ability to work independently and drive projects to successful outcomes
- Robust cross-functional collaboration skills and ability to work in a global environment
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance