Senior Vice President, Regulatory Affairs

Role: Senior Vice President of Regulatory Affairs responsible for leading global regulatory strategy throughout Mineralys' development and commercialization of biopharmaceuticals targeting hypertension and cardiometabolic diseases, including small molecules like lorundrostat. Responsibilities: shape submission strategies, oversee health authority interactions, manage post-approval filings, develop ex-US regulatory plans, and align cross-functional teams on regulatory compliance and growth objectives. Lead and grow the Regulatory Affairs organization, ensuring regulatory plans support clinical development, lifecycle expansion, and market launch readiness. Collaborate with Clinical Development, CMC, Quality, Commercial, and Legal teams; build external regulatory partnerships. Requirements: 15+ years in Regulatory Affairs within biopharma, with extensive experience in NDA/MAA submissions, global regulatory strategy, and lifecycle management. Proven leadership in a commercial-stage biotech/pharma environment, with strong knowledge of ICH, FDA, and EMA regulations, especially related to small molecules and cardiometabolic indications. Preferred: advanced scientific or healthcare degree (e.g., PharmD, PhD, MD). HighValue: global regulatory strategy, lifecycle expansion, NDA/MAA experience, small molecule and cardiometabolic focus, post-marketing compliance, cross-functional leadership. WorkSetup: fully remote; travel up to 20%.