Associate Director, Project Manager - Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Project Manager - Regulatory Affairs based in United States. This is a strategic regulatory project management leadership role supporting global development programs in the rare disease space. You will coordinate complex regulatory activities across multiple functions, ensuring submissions, milestones, and commitments remain aligned with program strategy. The role combines hands-on project management with cross-functional leadership and executive visibility. You will work closely with Regulatory Affairs, Clinical, CMC, Quality, Medical Writing, Operations, and external partners. A key focus will be building scalable timelines, dashboards, processes, and governance practices that improve regulatory execution. The position offers the opportunity to influence how global regulatory programs are planned, monitored, and delivered. You’ll join a collaborative, fast-paced environment where your work directly contributes to advancing therapies for patients with significant unmet needs.