Sr. Director, North America Regulatory Liaison

Role: Senior Director, North America Regulatory Liaison, leading regulatory strategy and execution for biopharma development programs. Responsibilities: shape regional regulatory pathways, manage submissions and interactions with Health Authorities (notably FDA), develop mitigation strategies, and coordinate cross-functional teams for lifecycle submissions. Serve as primary contact with regulatory agencies, lead or contribute to global regulatory planning, and influence decision-making within the organization. Qualifications: minimum 10+ years of regulatory experience in biotech/pharma, with strong knowledge of clinical development and lifecycle submission management (IND, NDA, CTA, MAA). Requires a master’s degree in a scientific discipline; advanced degrees (PharmD, Ph.D.) preferred. Experience in the liver therapeutic area and interaction with FDA is required; global Health Authority engagement is a plus. Demonstrated leadership, stakeholder management, strategic thinking, and communication skills are essential. High-value specifics include focus on late-stage development, regulatory submissions, global/regional frameworks, and cross-functional collaboration in a matrixed environment. Location: not specified, likely hybrid or remote depending on organization policies.