CMC Regulatory Consultant

Job Summary

Providing strategic regulatory leadership, the remote CMC Regulatory Consultant will guide the development of innovative oligonucleotide therapeutics, offering expertise from early development through IND submission.

Key responsibilities

• Provide strategic CMC regulatory guidance throughout product development
• Review and advise on drug substance, drug product, manufacturing, analytical methods, and control strategies
• Lead or contribute to IND CMC sections, FDA briefing packages, and regulatory responses

Required qualifications

• Advanced scientific degree (PhD, PharmD, MS, or equivalent)
• 10+ years of CMC regulatory experience within pharmaceutical or biotechnology organizations
• Deep expertise supporting oligonucleotide therapeutics (antisense oligonucleotides, siRNA, RNA therapeutics, or related technologies)
• Extensive experience authoring or reviewing IND CMC submissions
• Strong knowledge of FDA CMC regulations and regulatory strategy