Senior Regulatory CMC Writer for Biologics (Remote)

TG Therapeutics, Inc.; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

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

Qualifications

• Experience writing Regulatory CMC content for BLA
• Strong understanding of CTD Module 3 and quality summaries
• Familiarity with FDA and ICH expectations for biologics

Responsibilities

• Lead authoring, editing, and finalization of BLA CMC content
• Transform source documents into regulator-ready text
• Ensure consistency of data and narratives across CTD sections
• Identify gaps, risks, and justification needs
• Drive writing plans and review cycles to meet timelines
• Collaborate with subject-matter experts across functions
• Provide Regulatory CMC guidance on FDA/ICH expectations
• Draft responses to FDA information requests and review questions
• Support preparation of briefing documents and amendments
• Coordinate with CMOs/CROs to obtain source information
• Maintain document control and traceability throughout writing

Skills

Regulatory CMC

BLA writing

CTD Module 3

FDA guidance knowledge

Regulatory writing

Education

BS/MS in Chemistry/Biochemistry/Engineer

PhD preferred

Job description

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