Director of Global Regulatory Affairs Strategy
EPM Scientific, San Mateo, CA, United States
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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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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