Senior Director, Regulatory Affairs CMC

Role: Senior Director of Regulatory Affairs CMC, leading strategic and operational oversight of CMC regulatory submissions for Mirum's biopharma portfolio. Responsibilities: develop and implement all CMC strategies supporting market applications, post-marketing commitments, and global development programs; ensure high-quality, timely submissions; interpret and discuss complex CMC data with cross-functional teams and health authorities; manage relationships with internal/external stakeholders; oversee dossier compliance with ICH standards and regional requirements; lead CMC discussions with regulators and prepare responses; mentor junior staff. Requirements: 12+ years in Regulatory Affairs CMC with experience in drug development, market filings (NDA, MAA, sNDA), and lifecycle management; advanced scientific degree (PhD preferred); proven success with small molecules and biologics, including late-stage development through commercialization; strong regulatory submission track record with FDA, EMA, and other authorities; excellent scientific, communication, leadership, and organizational skills; ability to work independently in a fast-paced, high-growth setting. HighValue: biopharma, CMC strategy, small molecules and biologics, late-stage development, global regulatory submissions, cross-functional collaboration, international travel (~5-10%). WorkSetup: remote with domestic/international travel.