Senior Vice President, Regulatory Affairs

Senior Vice President, Regulatory Affairs

US Remote

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit  .

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Mineralys is a fully remote company.

Mineralys is seeking an accomplished, strategic Senior Vice President of Regulatory Affairs to lead global regulatory strategy across our development and commercial portfolio and serve as a key member of the Leadership Team. This leader owns the regulatory function end-to-end; shaping submission strategy, maintaining agency relationships, and ensuring compliance across all stages of the product lifecycle.

• Drive the global regulatory strategy partnering with Clinical Development to shape development plans, trial designs, and endpoints.
• Provide executive oversight and strategic direction for health authority interactions, including product labeling and safety changes
• Oversee global post-approval submissions, including supplemental NDAs, line extensions, manufacturing variations, and renewals.
• Build the ex-US regulatory approach across priority markets, applying reliance and joint-review pathways where they accelerate global development plans.
• Lead commercialization activities and cross-functional alignment across departments including Commercial, Medical Affairs, Quality, and Supply Chain.
• Ensure timely submission of periodic safety update reports and annual reports, and compliance with global post-marketing commitments.
• Serve as the senior regulatory authority for the company, building and maintaining productive relationships with regulatory agencies and external advisors.
  
  Partner with the Executive team and cross-functional leaders across Clinical Development, Commercial, Quality, CMC, and Legal to align growth objectives, regulatory strategy, and risk management.
• Build, lead, and develop a high-performing global Regulatory Affairs function with clear accountability, strong succession, and fit-for-purpose capabilities.
• Build and evolve the Regulatory Affairs organization, capabilities, processes, and external partnerships needed to support Mineralys through commercialization and the company’s continued growth.
• Provide strategic and operational guidance to project teams to ensure regulatory submissions and compliance activities support corporate objectives.

• 15+ years of progressively responsible Regulatory Affairs experience in the biopharmaceutical industry, including significant experience leading regulatory strategy and teams.
• Successful experience with NDA submissions and major health authority interactions; MAA experience strongly preferred. Experience with small molecules and cardiometabolic diseases is preferred.
• Proven track record leading regulatory strategy for lifecycle expansion, working closely with Clinical Development on programs, expedited pathways, and global launch readiness.
• Experience in a commercial-stage biotechnology or pharmaceutical environment, with strong knowledge of regulatory requirements for product labeling, promotional review, and post-marketing commitments.
• Mastery of ICH guidelines, FDA and EMA post-marketing regulations, labeling negotiations, and CMC lifecycle requirements.
• Strong cross-functional leadership experience, particularly with Clinical Development, CMC, Quality, Commercial, and Legal teams.
• Proven track record of building and mentoring high-performing regulatory teams and influencing executive strategy.
• Advanced degree preferred, including PharmD, PhD, MD, or equivalent in a scientific or healthcare discipline.

• Trusted Decision Maker
  - Serve as the senior regulatory authority internally, confidently guiding teams and executives on critical development, go or no-go, submission, and labeling decisions.
• Self-Directed and Proactive
  - Identify risks and opportunities early and bring forward clear recommendations without waiting for instruction.
• Leads from the Front
  - Model high standards, integrity, quality, and accountability as a trusted company…