This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, CMC Regulatory Affairs based in United States. This role offers the opportunity to lead global CMC regulatory strategy for innovative biologic and combination products within a fast-growing biotechnology environment.You will play a key role in advancing therapies from clinical development through commercialization by ensuring strong regulatory pathways and execution.Working closely with scientific, quality, manufacturing, clinical, and external partners, you will influence critical development decisions and regulatory outcomes.The position combines strategic leadership with hands-on regulatory expertise, requiring strong scientific judgment and cross-functional collaboration.You will guide submissions, health authority interactions, lifecycle activities, and regulatory strategies across multiple development stages.This is an ideal opportunity for an experienced regulatory leader who wants to make a direct impact in a mission-driven biotech organization.