Senior Director, CMC Regulatory Affairs - 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. The company is headquartered in Radnor, Pennsylvania.

The Senior Director, CMC Regulatory Affairs leads strategies for chemistry, manufacturing, and controls in drug development programs. This role ensures regulatory compliance for advancing lorundrostat and future pipeline candidates through clinical stages. Responsibilities include overseeing CMC documentation and interactions with health authorities.

Mineralys operates as a fully remote company, enabling flexible work across the US. Team members collaborate virtually on innovative therapies addressing unmet needs in cardiovascular and kidney diseases. The environment supports cross-functional efforts in a dynamic biopharma setting.

This position offers opportunities to shape global regulatory submissions and contribute to breakthrough treatments. Join a focused team driving aldosterone-targeted medicines forward. For more information, visit https://mineralystx.com and follow on LinkedIn, Twitter, and Bluesky.