Senior Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs responsible for developing and executing global regulatory strategies across Ardelyx's product portfolio, from early development to post-approval. Responsibilities: serve as primary regulatory strategist on cross-functional teams, lead interactions with FDA, EMA, and other agencies, oversee IND/CTA, BLA/NDA/MAA submissions, ensure regulatory compliance, and manage a regulatory team. Provide strategic input on clinical trial design, monitor regulatory landscape, and communicate updates to leadership. Qualifications: 12+ years in regulatory affairs within pharma/biotech, with successful BLA/NDA/MAA leadership, deep FDA and international regulation expertise, and experience across modalities or therapeutic areas. Preferred: RAC certification, experience with expedited programs, and global regulatory exposure. High-Value: biopharma focus on drug development, regulatory strategy, cross-cultural agency interactions, and lifecycle management. Work Setup: full-time, likely hybrid or remote, with international regulatory responsibilities.