Senior Director, Advertising and Promotion - 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, Advertising & Promotion, Regulatory Affairs (Ad & Promo) will lead all regulatory activities related to medical and promotional material development, review, and external communications for Mineralys as it advances toward commercialization. This individual will serve as the primary regulatory representative on the Medical, Legal and Regulatory (MLR) team, ensuring that all promotional, non-promotional and scientific exchange materials adhere to internal policies, relevant laws, FDA regulations, and industry standards.

This is a highly visible, hands-on role ideal for a strategic, detail-oriented, and collaborative regulatory leader who thrives in a fast-moving, small-company environment and is comfortable building Ad & Promo infrastructure under launch timelines.

Key Responsibilities

Strategic Leadership

• Serve as the Regulatory lead on the MLR team, providing timely, compliant strategic guidance for all promotional and non-promotional materials development.
• Interpret and apply FDA Advertising & Promotion regulations, guidance, OPDP expectations and enforcement trends, to company materials.
• Serve as a strategic thought partner with Marketing and Medical Affairs to develop compliant and compelling prom