Consultant, Regulatory CMC – 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

Title: Consultant, Regulatory CMC – BLA Writing

Location: Remote

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.TGTherapeutics.com.

Role

TG Therapeutics is seeking an experienced Regulatory CMC consultant with demonstrated Biologics License Application (BLA) writing experience to provide hands‑on authoring and submission support for biologic products. The consultant will serve as a senior CMC regulatory writing resource, translating complex technical information into clear, accurate, consistent, and submission‑ready content aligned with FDA and ICH expectations.

The primary focus of this engagement is authoring, reviewing, and integrating CMC content for a BLA, specifically on Module 3 and related Quality content. The consultant will work closely with Regulatory CMC, Technical Operations, Quality, analytical, process development, manufacturing, and external partners to identify content gaps, resolve issues, maintain consistency across sections, and support timely delivery of a high‑quality marketing application.

ENGAGEMENT FOCUS: This is a hands‑on consulting role intended for an experienced Regulatory CMC writer who can quickly integrate into an active BLA program, independently own assigned sections, and deliver submission‑ready content on schedule.

Key Responsibilities

• Lead hands‑on authoring, editing, and finalization of BLA CMC content, including CTD Module 3 sections and associated Quality summaries, as assigned.
• Transform source documents, technical reports, manufacturing data, specifications, validation information, and subject‑matter‑expert input into clear, concise, and regulator‑ready submission text.
• Ensure consistency of data, terminology, claims, control strategy, and technical narratives across BLA sections and supporting documents.
• Perform detailed content reviews to identify gaps, inconsistencies, regulatory risks, and areas requiring additional technical justification or source documentation.
• Drive section‑level writing plans, content requests, review cycles, comment resolution, and readiness against submission timelines.
• Collaborate closely with CMC subject‑matter experts across process development, manufacturing, analytical development, quality control, Quality, and Technical Operations.
• Provide Regulatory CMC guidance on FDA and ICH expectations applicable to biologics marketing applications and recommend practical approaches to strengthen submission content.
• Draft and/or support responses to CMC‑related questions from FDA, including information requests and review questions arising during BLA review.
• Support preparation of briefing documents, meeting packages, amendments, and other CMC regulatory documents related to the BLA, as needed.
• Coordinate with external partners, CMOs, CROs, and other consultants to obtain source information and ensure deliverables are complete, accurate, and submission‑ready.
• Maintain strong document control and traceability of source information, assumptions, open issues, and authoring decisions throughout the writing process.

Professional Experience/Qualifications

• Demonstrated, 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.
• Significant Regulatory CMC experience in the pharmaceutical or biotechnology industry, preferably supporting biologics (MAB) from late‑stage development through BLA submission and review.
• Experience with monoclonal antibody products strongly preferred.
• Strong technical CMC background with the ability to understand and synthesize information related to drug substance and drug product manufacturing, process controls, analytical methods, specifications, stability, validation, and quality control.
• Demonstrated knowledge of FDA biologics CMC expectations, CTD/eCTD structure, and relevant ICH guidance.
• Ability to independently develop high‑quality regulatory narratives from incomplete or complex technical source material and efficiently close content gaps with subject‑matter experts.
• Experience supporting FDA CMC information requests, review questions, amendments, and/or post‑submission interactions is highly desirable.
• Excellent scientific and regulatory writing, editing, and document‑integration skills, with exceptional attention to detail and consistency.
• Proven ability to work effectively in a consulting environment, manage multiple deliverables, and meet aggressive submission timelines with limited supervision.
• Strong interpersonal and communication skills with the ability to collaborate effectively across internal functions and external manufacturing or development partners.

Education

• BS/MS in a scientific or engineering discipline (e.g., Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences) or a related field.
• Advanced degree (PhD) preferred but not required with substantial relevant BLA and Regulatory CMC experience.

Applicants must be currently authorized to work in the United States on a full‑time basis. The company does not sponsor employment visas for this position.

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy‑related condition or any other protected characteristic.