Senior Regulatory CMC Writer Biologics; Remote
San Jose, Santa Clara County, California, 95199, USA
Listed on 2026-09-29
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Business
Regulatory Compliance Specialist
TG Therapeutics, Inc. is seeking an experienced Regulatory CMC consultant with BLA writing expertise to provide hands-on authoring and submission support for biologics.
The role focuses on Module 3 and related Quality content, collaborating with cross-functional teams to deliver regulator-ready CMC narratives and respond to FDA requests, while maintaining rigorous document control and traceability. This remote engagement requires excellent scientific writing, strong regulatory knowledge of FDA
Are you ready to take on the Senior Regulatory CMC Writer for Biologics (Remote) role at TG Therapeutics, Inc.?
The following position is for a Senior Regulatory CMC Writer for Biologics (Remote) with TG Therapeutics, Inc.
Our team is growing, and we are hiring a Senior Regulatory CMC Writer for Biologics (Remote) in United States.
This Full Time position is for the Senior Regulatory CMC Writer for Biologics (Remote) role at TG Therapeutics, Inc.
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