Regulatory CMC Director — Biologics/MSAT (Remote/NC)

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

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