Senior Vice President, Regulatory Affairs

The role

The Senior Vice President, Regulatory Affairs will lead global regulatory strategy across the development and commercial portfolio. This leader owns the regulatory function end-to-end and serves as a key member of the Leadership Team.

What you will do

• Drive the global regulatory strategy partnering with Clinical Development
• Provide executive oversight and strategic direction for health authority interactions
• Oversee global post-approval submissions
• Build the ex-US regulatory approach across priority markets
• Lead commercialization activities and cross-functional alignment
• Ensure timely submission of periodic safety update reports and annual reports
• Serve as the senior regulatory authority for the company
• Partner with the Executive team and cross-functional leaders
• Build, lead, and develop a high-performing global Regulatory Affairs function
• Build and evolve the Regulatory Affairs organization, capabilities, processes, and external partnerships

Required qualifications

• 15+ years of progressively responsible Regulatory Affairs experience in the biopharmaceutical industry
• Significant experience leading regulatory strategy and teams
• Successful experience with NDA submissions and major health authority interactions
• Proven track record leading regulatory strategy for lifecycle expansion
• Experience in a commercial-stage biotechnology or pharmaceutical environment
• Mastery of ICH guidelines, FDA and EMA post-marketing regulations, labeling negotiations, and CMC lifecycle requirements
• Strong cross-functional leadership experience

Nice to have

• MAA experience
• Experience with small molecules and cardiometabolic diseases
• Advanced degree, including PharmD, PhD, MD, or equivalent in a scientific or healthcare discipline

Benefits

• medical
• dental
• vision
• time off
• 401K
• participating in Mineralys incentive plans contingent on achievement of personal and company performance

About the company

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania.