Senior Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs responsible for developing and executing global regulatory strategies across Ardelyx's product portfolio, supporting pipeline and marketed therapeutics. Responsibilities: lead regulatory planning for early development through post-approval, manage interactions with FDA, EMA, and other authorities, oversee IND/CTA, BLA/NDA, and MAA submissions, and ensure regulatory compliance and readiness. Collaborate with Clinical Development, Medical Affairs, and leadership, providing strategic guidance on trial design, regulatory pathways, and risk management. Lead and mentor the regulatory team, monitor evolving regulatory landscapes, and communicate impact to stakeholders. Requirements: bachelor's degree in life sciences or related field; 12+ years of regulatory experience in pharma/biotech, with a proven track record in BLA/NDA/MAA submissions. Deep expertise in FDA regulations (21 CFR, ICH), with knowledge of EMA and global frameworks. Strong leadership, strategic thinking, and stakeholder management skills; RAC certification (preferred). High-Value: experience with biologics, small molecules, gene therapy, or combination products; global regulatory experience; familiarity with expedited pathways like Breakthrough Therapy or Fast Track; working knowledge of international regulations. Work setup: not specified.