Associate Director, 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, 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. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1