Senior Vice President, Regulatory Affairs

Mineralys Therapeutics, Inc.; United States; On-site; USD 250,000 - 350,000; Full time

Job summary

Mineralys is seeking a Senior Vice President of Regulatory Affairs to lead global regulatory strategy across development and commercialization of biopharmaceuticals, including cardiometabolic programs. You will guide NDA/MAA submissions, coordinate health authority interactions, and align cross-functional teams on lifecycle planning and market launch readiness.

The role requires 15+ years in Regulatory Affairs, strong leadership in commercial-stage biotech/pharma, and deep knowledge of ICH, FDA,

Qualifications

• 15+ years in Regulatory Affairs with extensive NDA/MAA submissions, global regulatory strategy, and lifecycle management.
• Strong leadership in a commercial-stage biotech/pharma with knowledge of ICH, FDA, EMA regulations; focus on small molecules and cardiometabolic indications.

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.

Skills

Global regulatory strategy

Leadership

NDA/MAA submissions

Lifecycle management

ICH FDA EMA knowledge

Education

Advanced degree (PharmD/PhD/MD)

Job description

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).

High Value

• 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%.