Senior Director, Regulatory Affairs

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve. Position Summary: The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio. This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring full compliance with applicable regulations and guidance. Responsibilities: Develop and own global regulatory strategies for pipeline and marketed products, from early development through post-approval lifecycle management Serve as the primary regulatory strategist on cross-functional development teams (CDTs), aligning regulatory planning with clinical and commercial objectives Provide regulatory intelligence and proactive risk assessment to senior leadership, including Board-level briefings when appropriate Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements Partner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications Review and provide regulatory input on protocols, IBs, CSRs, and other clinical documents to ensure alignment with regulatory strategy Lead