Senior Director, CMC Regulatory Affairs

“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 https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”

Mineralys is a fully remote company.

The Senior Director, CMC (Chemistry, Manufacturing, and Controls) Regulatory is responsible for leading the development, execution, and maintenance of global CMC regulatory strategy to support clinical development, registration, commercialization and lifecycle management of Mineralys products. This role provides strategic and operational leadership for all CMC-related regulatory activities, supporting cross-functional decision-making by providing regulatory guidance, ensuring compliance of CMC documentation and high-quality submissions that meet global regulatory requirements and support business objectives. The Sr. Director partners closely with CMC, Quality, and external partners to ensure alignment of CMC documentation, regulatory strategy, product lifecycle p