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
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