Senior Vice President, 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.

• 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.

• 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).

• Global regulatory strategy
• Lifecycle expansion
• NDA/MAA experience
• Small molecule and cardiometabolic focus
• Post-marketing compliance
• Cross-functional leadership

Work Setup: fully remote; travel up to 20%.