Senior Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs responsible for developing and executing global regulatory strategies across Ardelyx's product portfolio, including pipeline and marketed products. Responsibilities: lead regulatory planning from early development through post-approval, serve as the primary strategist on cross-functional teams, manage interactions with FDA, EMA, and other authorities, oversee regulatory submissions (IND, BLA/NDA, MAA), review clinical documents, and ensure compliance with evolving regulations. Build and mentor regulatory teams and communicate regulatory intelligence to leadership. Requirements: Bachelor's in life sciences or related field, 12+ years in pharmaceutical/biotech regulatory affairs, proven success with BLA/NDA/MAA submissions, deep FDA guidance knowledge, experience managing high-stakes agency interactions, and leadership skills. Preferred: RAC certification, experience across modalities (small molecule, biologics, gene therapy), global regulatory experience, and familiarity with expedited programs (Fast Track, Breakthrough). HighValue: focus on biologics or small molecules, global regulatory strategy, multiple therapeutic areas, and lifecycle management. WorkSetup: not specified.