Director US Regulatory Strategy

Role: Lead US Regulatory Affairs Strategy for biopharmaceutical products, overseeing development, approval, and lifecycle management with a focus on US and global products. Responsibilities: direct cross-functional team leadership, US product registration, documentation assembly for FDA submission, liaising with FDA, and providing strategic regulatory advice for clinical and marketing phases. Responsibilities also include monitoring global legislation, training teams, and managing alliance product regulatory activities. Qualifications: Bachelor's degree in life sciences or related field, 10+ years in pharma/biotech with 7+ years in Regulatory Affairs, experience supporting small molecules and biologics, and proven success in FDA interactions and regulatory strategy. Preferred: advanced degrees (Masters/Doctorate), international regulatory exposure, and FDA experience. HighValue: focus on brain health therapeutics, biologics and small molecules, US and global regulatory compliance, investigational and marketed product registration, and stakeholder engagement. WorkSetup: hybrid with up to 20% domestic travel; international travel may be required.