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

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 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. #J-18808-Ljbffr TG Therapeutics, Inc.