Assoc. Dir./Dir./Sr. Director, Regulatory CMC

TG Therapeutics, Inc.; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

TG Therapeutics, Inc. is seeking an Associate Director/Director/Sr. Director, Regulatory CMC to lead global CMC regulatory strategy and submissions for clinical and commercial products.

This role reports to the VP of Regulatory CMC and collaborates with Quality, Technical Operations, and external partners to ensure compliance and timely filings. The candidate will oversee IND/BLA/CMC submissions, provide risk mitigation guidance, and manage cross-functional teams across regions, helping drive

Qualifications

• 5–10 years Regulatory CMC experience in pharmaceutical/biotechnology.
• 5–10 years MSAT for monoclonal antibody products.
• Strong technical CMC background incl. analytics, process development, manufacturing, QC.
• Biologics (monoclonal antibodies) experience required; cell-based therapies preferred.
• Knowledge of device & combination product regulatory requirements (21 CFR Part 4, ISO 13485).
• Experience preparing CMC sections for INDs, BLAs, and/or NDAs; amendments and post-approval supplements.
• Strong project management and organizational skills; ability to manage multiple priorities.
• Effective communicator with cross-functional teams and ability to present complex info clearly.
• Experience collaborating with CMOs and global regulatory agencies.

Responsibilities

• Coordinate, prepare, review, and oversee regulatory filings (INDs, BLAs, DMFs, CTAs, amendments, updates, briefing documents, post-approval submissions).
• Lead authorship and coordination of CMC sections of regulatory submissions.
• Draft and coordinate responses to CMC-related questions from FDA and health authorities.
• Partner with internal functions and external stakeholders (CMOs, CMOs, consultants) to align regulatory strategy.
• Serve as the CMC regulatory point of contact for assigned projects.
• Interpret and communicate regulatory expectations across the organization.
• Maintain current knowledge of global regulatory requirements (FDA, ICH, EMA).
• Support CMC aspects of lifecycle management, including post-approval changes.
• Develop relationships with regulatory agencies and external partners.

Skills

Regulatory CMC

MSAT for MAB

Analytical methods

Monoclonal antibodies

Regulatory submissions

Device regulations

Cross-functional collaboration

Project management

CRO/CMO coordination

Regulatory liaison

Education

BS/MS in science or engineering

PhD preferred

Job description

Location: North Carolina/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

The Associate Director/Director/Sr. Director, Regulatory CMC reports to the Vice President of Regulatory CMC and is responsible for managing the Company’s Regulatory CMC function to enable clinical development, marketing authorization, manufacture, and distribution of clinical supplies and commercial products. This individual supports the strategic and operational leadership required to ensure Regulatory CMC compliance with global (both U.S. and ex-U.S.) regulations and submission requirements for clinical studies and commercial supply.

This Regulatory CMC leader is accountable for developing and executing global CMC regulatory strategies, providing guidance on risk mitigation, and resolving submission-related issues. The role requires effective collaboration with internal Quality and Technical Operations functions, as well as external partners and suppliers. The successful candidate will contribute to the growth of the organization as pipeline assets advance through development and commercialization.

Key Responsibilities

• Coordinate, prepare, review, and oversee the timely submission and maintenance of regulatory filings (INDs, BLAs, DMFs, CTAs, amendments, annual updates, briefing documents, pre-meeting packages, post-approval submissions, and marketing applications to the FDA and other global regulatory authorities).
• Lead the authorship and coordination of CMC sections of regulatory submissions, ensuring accuracy, consistency, and regulatory compliance.
• Draft and coordinate responses to CMC-related questions from the FDA and other health authorities in collaboration with cross-functional teams.
• Partner with internal functions and external stakeholders (CROs, CMOs, and consultants) to ensure alignment on regulatory strategy, timelines, and deliverables.
• Serve as the CMC regulatory point of contact for assigned projects, providing regulatory expertise to support product development, manufacturing, and quality control.
• Interpret and communicate regulatory expectations, guidelines, and changes to stakeholders across the organization.
• Maintain current knowledge of global regulatory requirements and evolving CMC regulations (FDA, ICH, EMA, and other regional authorities).
• Support CMC aspects of product lifecycle management, including post-approval changes and global submissions.
• Develop and maintain productive relationships with regulatory agencies and external partners.

Professional Experience/Qualifications

• 5–10 years of experience in Regulatory CMC within the pharmaceutical or biotechnology industry, with progressive responsibility.
• 5–10 years of experience in MSAT for MAB biological products.
• Strong technical CMC background, including in-depth understanding of analytical methods, process development, manufacturing, and quality control.
• Experience with biologics (monoclonal antibodies) required; experience with combination products and/or cell-based therapies preferred.
• Demonstrated expertise in Regulatory CMC requirements from early clinical phases through commercialization and lifecycle management.
• Knowledge of device and combination product regulatory requirements (21 CFR Part 4, ISO 13485, etc.), including understanding of device constituent part development, compatibility, and regulatory expectations.
• Proven ability to interpret regulatory guidelines and translate them into actionable strategies for development programs.
• Experience preparing and submitting CMC sections of INDs, BLAs, and/or NDAs, including amendments and post-approval supplements.
• Strong project management and organizational skills; ability to manage multiple priorities in a fast-paced environment.
• Effective communicator with the ability to influence cross-functional teams and present complex information clearly to both technical and non-technical audiences.
• Experience collaborating with contract manufacturing organizations (CMOs) and global regulatory agencies.

Education

• BS/MS in a scientific or engineering discipline (e.g., Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences).
• Advanced degree (PhD) preferred.

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.