Remote SVP, Regulatory Strategy & Lifecycle Growth

Scorpion Therapeutics; United States; Remote; 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

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,