Remote Regulatory CMC Consultant for BLA Writing

TG Therapeutics, Inc.; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Regulatory CMC consultant to lead hands-on authoring for a BLA, focusing on Module 3 and related Quality content. Remote engagement with cross-functional teams.

The role requires substantial experience as a primary author, deep regulatory knowledge of FDA/ICH expectations for biologics, and the ability to deliver submission-ready content on schedule. Applicants should have BS/MS in a scientific field and demonstrate strong writing, editing, and coordination

Qualifications

• Recent experience as a primary author or lead writer of CMC content for at least one BLA; direct experience writing substantial portions of CTD Module 3 is required.
• Experience with monoclonal antibody products strongly preferred.
• Strong technical CMC background covering drug substance and drug product manufacturing, process controls, analytical methods, specifications, stability, validation, and quality control.
• Knowledge of FDA biologics CMC expectations, CTD/eCTD structure, and ICH guidance.
• Ability to develop high-quality regulatory narratives from complex source material and fill gaps with SME input.
• Experience supporting FDA CMC information requests, review questions, amendments, and post-submission interactions is desirable.
• Excellent scientific and regulatory writing, editing, and document-integration skills with attention to detail.
• Proven ability to work in a consulting environment, manage multiple deliverables, and meet tight submission timelines.
• Strong interpersonal and cross-functional collaboration skills.

Responsibilities

• Lead hands-on authoring, editing, and finalization of BLA CMC content, including CTD Module 3 sections and related Quality summaries.
• Transform source documents, technical reports, manufacturing data, specifications, validation information into regulator-ready submission text.
• Ensure consistency of data, terminology, and narratives across BLA sections and documents.
• Perform detailed content reviews to identify gaps, regulatory risks, and need for additional documentation.
• Drive section-level writing plans, content requests, review cycles, and submission readiness timelines.
• Collaborate with CMC SMEs across process development, manufacturing, analytical development, quality control, and operations.
• Provide Regulatory CMC guidance on FDA/ICH expectations and practical approaches to strengthen submissions.
• Draft and support responses to FDA CMC questions and information requests.
• Support briefing documents, amendments, and other CMC regulatory documents for the BLA.
• Coordinate with CMOs, CROs, and external consultants to obtain source information and ensure completeness.
• Maintain document control and traceability of source information and decisions.

Skills

Regulatory CMC writing

BLA writing

CTD Module 3

Biologics (MAB)

FDA/ICH guidance

Regulatory communication

Independent writing

Education

BS/MS in Chemistry, Biochemistry or related field

PhD preferred

Job description

TG Therapeutics, Inc. is seeking a Regulatory CMC consultant to lead hands-on authoring for a BLA, focusing on Module 3 and related Quality content. Remote engagement with cross-functional teams.

The role requires substantial experience as a primary author, deep regulatory knowledge of FDA/ICH expectations for biologics, and the ability to deliver submission-ready content on schedule. Applicants should have BS/MS in a scientific field and demonstrate strong writing, editing, and coordination