Senior Director / Executive Director, US Regulatory Strategy
New
V
VCLSBiotechnology and Pharmaceutical Consulting
Remote; Boston, Massachusetts, United States. San Francisco, California, United StatesFull-TimeDirector
Salary not disclosed
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Job Details
Requirements
- Degree in a life sciences discipline.
- Significant industry experience in regulatory strategy.
- Deep expertise in US FDA regulatory strategy for biologics.
- Multiple successful BLA experiences with direct FDA interactions.
- Significant experience with complex modalities, specifically combination products and cell and gene therapies.
- Strong consulting, leadership, communication, and presentation skills.
- Commercially minded with business acumen for client development.
Responsibilities
- 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.
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