Senior Director / Executive Director, US Regulatory Strategy
VCLS (Voisin Consulting Life Sciences) · Boston, MA · 2 wk ago
RemoteRemoteManagementFull-time
Key Responsibilities
- Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management
- Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics
- Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy
- Lead all aspects of health authority interactions
- Support regulatory due diligence activities
Requirements
- Required Qualifications
- Degree in a life sciences discipline
- Significant industry experience
- Deep expertise in US FDA regulatory strategy for biologics
- Multiple successful BLA experiences with direct FDA interactions
- Significant experience with complex modalities, such as combination products and cell and gene therapies
- Strong consulting, leadership, communication, and presentation skills