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Salary: USD 350,000 - 390,000 / annual
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines to treat hypertension and related comorbidities including chronic kidney disease, obstructive sleep apnea, and aldosterone-driven diseases. The company's lead candidate, lorundrostat, is a proprietary oral aldosterone synthase inhibitor.
We are seeking an accomplished 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 role owns the regulatory function end-to-end, shaping submission strategy, maintaining agency relationships, and ensuring compliance across all stages of the product lifecycle.
Key responsibilities include:
- Drive 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
- Lead commercialization activities and cross-functional alignment across Commercial, Medical Affairs, Quality, and Supply Chain
- Ensure timely submission of periodic safety update 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
- Build, lead, and develop a high-performing global Regulatory Affairs function with clear accountability and succession planning
- Provide strategic and operational guidance to project teams to ensure regulatory submissions support corporate objectives
This position requires up to 20% travel, frequently outside the local area and overnight.
Requirements:
- 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 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
