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, Regulatory Affairs based in the United States.
This is an opportunity to play a key role in advancing innovative therapies for patients with serious diseases within a clinical-stage biotechnology environment.
You’ll contribute to global regulatory strategy and execution across the full product development lifecycle, with a strong focus on FDA interactions and submissions.
The role offers meaningful exposure to oncology and rare disease programs, including complex regulatory pathways and multiple development phases.
You’ll work closely with Clinical, Project, Study, and other cross-functional teams to translate regulatory requirements into practical development strategies.
You’ll also support agency interactions, submission planning, regulatory operations, and external partners while helping manage risks and timelines.
The position is suited to a strategic, detail-oriented regulatory professional who thrives in a collaborative, fast-moving, mission-driven setting.
Your work will directly contribute to bringing potentially life-changing medicines from development toward patients who need them.