- Barcelona, Catalonia, Spain
- Hybrid
- Full-time · Manager
- 5+ years
Lead global and regional regulatory strategy, manage regulatory submissions, interact with health authorities, and oversee regulatory milestones for assigned products.
Responsibilities
- Lead development and implementation of regional or global regulatory strategy
- Lead cross-functional teams in major health authority interactions
- Prepare regulatory strategy documents and target product labeling
- Negotiate with health authorities
- Update senior management on project risks and mitigation
Requirements
- Advanced degree in a science related field
- Nice to have: Benefit/risk profile
- Nice to have: Dose selection
- Nice to have: Statistical design
- Nice to have: Experience in small molecules & biologics