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.
The successful candidate will serve as a trusted strategic advisor to clients pursuing late-stage development and commercialization of complex biologics, such as combination products, with a particular emphasis on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable.
In addition to technical regulatory leadership, this role requires strong client-facing skills, business acumen, and the ability to contribute to the growth of a boutique consultancy through thought leadership, client development, and industry engagement.
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.
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.
