Senior Director, Global Regulatory Affairs, Team Lead, Strategy (Europe & RoW)
Genmab(2 months ago)
About this role
Senior Director within Genmab’s Global Regulatory Affairs organization responsible for leading Europe/Rest of World regulatory strategy for assigned antibody development and marketed products. The role serves as a senior leader and primary EMA contact for portfolio programs, mentoring a team of Regulatory Strategists and ensuring regional strategies align with global development and commercial objectives. This position reports to the Head of Regulatory Affairs and supports cross-functional, global program coordination.
Required Skills
- Regulatory Strategy
- EMA Interactions
- Health Authorities
- Clinical Submissions
- MAA Submissions
- Project Management
- Team Leadership
- CRO Oversight
- CMC Changes
- Labeling Review
+2 more
Qualifications
- Bachelor's Degree in Scientific Discipline
- PhD
- MD
About Genmab
genmab.comGenmab is an international biotech company specializing in antibody therapeutics for the treatment of cancer and other serious diseases
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