- Lead development and execution of US and global regulatory strategy across all development stages, with emphasis on late-stage, 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/clinical requirements, and labeling.
- Manage all aspects of health authority interactions and support regulatory due diligence.
- Serve as primary client contact, building long-term relationships and delivering high-quality strategic advice.
- Lead multidisciplinary consulting teams and mentor junior staff members.
- Support business development, client proposals, and industry thought leadership.