Global Regulatory Advertising & Promotion Leader

Mirum Pharmaceuticals; Foster City (CA); Hybrid; USD 240,000 - 260,000; Full time

Job summary

Mirum Pharmaceuticals is seeking a Director of Global Regulatory Affairs Advertising & Promotion to lead commercial regulatory activities and ensure compliant, timely submissions of promotional materials. The role partners with MLR, medical, legal, and regulatory teams and liaises with FDA OPDP to shape strategy for US labeling and global markets.

This senior leader will drive regulatory initiatives, maintain up-to-date knowledge of FDA requirements, and oversee cross‑functional collaboration in

Qualifications

• Minimum 10–12 years in Regulatory Affairs with a focus on advertising and promotional materials.
• Direct experience with FDA OPDP submissions and regulatory strategies.
• Experience with USPI and global labeling documents preferred.
• Excellent written and verbal communication and cross-functional leadership.

Responsibilities

• Provide strategic and operational regulatory leadership for commercial programs.
• Serve as a regulatory A&P SME for advertising materials.
• Liaise with FDA/CDER/OPDP and other health agencies.
• Oversee submissions and coordinate with publishing vendors.
• Lead MLR processes and drive timely regulatory deliverables.

Skills

OPDP experience

Regulatory leadership

Cross-functional collaboration

Education

Bachelor’s or advanced degree in a scientific discipline

Job description

Mirum Pharmaceuticals is seeking a Director of Global Regulatory Affairs Advertising & Promotion to lead commercial regulatory activities and ensure compliant, timely submissions of promotional materials. The role partners with MLR, medical, legal, and regulatory teams and liaises with FDA OPDP to shape strategy for US labeling and global markets.

This senior leader will drive regulatory initiatives, maintain up-to-date knowledge of FDA requirements, and oversee cross‑functional collaboration in