About the Job

We're seeking an experienced CMC Regulatory Consultant to provide strategic regulatory leadership for the development of an innovative therapeutic utilizing advanced oligonucleotide and targeted intracellular drug delivery technologies.

This is an opportunity to work alongside a cutting-edge development team, helping shape CMC strategy from early development through IND submission while supporting groundbreaking science.

What You'll Do

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.
Identify regulatory risks and recommend practical mitigation strategies.
Collaborate with cross-functional teams and CDMO partners to support successful development and regulatory milestones.

What We're Looking For

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.
Experience working with CDMOs and multidisciplinary development teams.

Preferred

Experience with targeted intracellular or endosomal drug delivery technologies.
Prior FDA regulatory experience or senior CMC leadership.
Background supporting successful IND submissions.

If you're a strategic regulatory expert who thrives at the intersection of innovative science and regulatory excellence, we'd love to hear from you.

Benefits

This position does not qualify for benefits.

Posted: July 27, 2026