Director of Global Regulatory Affairs Strategy

Director of Regulatory Affairs

Hybrid - San Mateo, CA
Salary: $190,000-$210,000 (negotiable for the right candidate)

Summary:

A global biopharmaceutical company specializing in photomedicine, rare metabolic disorders, and peptide‑based therapeutics is seeking a tenacious Director of Regulatory Affairs to lead U.S. and global regulatory strategy across a pipeline spanning pre‑clinical through commercial programs. The company develops treatments for severe photosensitivity and other genetic, metabolic, and life‑threatening conditions, with a growing U.S. hub in the Bay Area. Hybrid schedule- 3 days onsite, 2 days remote, relocation assistance available.

Responsibilities:

• Reporting to the CEO this leader will:
• Direct regulatory strategy for six programs across development stages
• Lead FDA interactions, including IND, NDA, and BLA pathways for a peptide biologic implant
• Manage a global regulatory team (U.S.& international reports)
• Collaborate cross‑functionally to guide development, submissions, and approvals
• Support continued expansion of U.S. operations and in‑house manufacturing capabilities

Qualifications

• 10-15 years of regulatory affairs experience in pharma/biotech
• Proven success leading FDA meetings and U.S. and global regulatory strategy
• Deep understanding of FDA, EMA, and global regulatory frameworks, with strong command of ICH guidelines.
• Experience with peptide biologics and/or implant products preferred
• Demonstrated track record of U.S. drug approvals
• Highly experienced across the full product lifecycle, from early development through late‑stage submissions and post‑approval management
• Strong communication, negotiation, and leadership skills