Senior Director / Executive Director, US Regulatory Strategy

We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology and pharmaceutical clients developing innovative and complex therapies. Key Responsibilities Regulatory Strategy Leadership 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. Experience with EMA and other international health authorities is highly valued. Client Leadership and Consulting Serve as a senior strategic advisor and primary client contact. Build long-term biotech and pharmaceutical client relationships. Lead multidisciplinary consulting teams and mentor junior staff. Deliver high-quality regulatory recommendations, reports, and presentations. Business Development and Growth Support business development, proposals, and client pitches. Represent the organization at conferences and industry events. Develop thought leadership materials and support company growth. Required Qualifications Degree in a lifesciences 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. #J-18808-Ljbffr VCLS