TG Therapeutics, Inc. · 1 month ago
Senior Director, Head of Regulatory Affairs
United States
Full-time
Remote
Director/Executive
15+ years expTG Therapeutics is a fully-integrated, commercial-stage biopharmaceutical company focused on developing novel treatments for B-cell diseases. The Senior Director, Head of Regulatory Affairs will lead the regulatory strategy for the company's portfolio and represent TG Therapeutics with global health authorities.
BiotechnologyHealth CareTherapeutics
Hiring Manager
Rachel Berger-Rosas, MBA
Responsibilities
Define and drive the global regulatory strategy across preclinical, clinical, and commercial programs
Serve as the company’s primary liaison with the FDA, EMA, and other regulatory agencies worldwide
Provide executive-level guidance to senior management on regulatory risks, opportunities, and emerging trends
Lead all global regulatory submissions, including INDs, CTAs, BLAs, NDAs, and MAAs
Oversee the preparation, quality review, and timely submission of regulatory documents, including responses to health authority requests, briefing packages, and meeting materials
Own and lead the label development process across TG Therapeutics’ products—from initial label strategy through negotiation and finalization with global health authorities
Partner closely with Clinical, Commercial, Medical Affairs, and Legal to ensure labeling accurately reflects the clinical data and supports commercial objectives
Drive the creation, maintenance, and revision of labeling content, including USPI, SmPC, and patient information leaflets, ensuring global alignment
Oversee labeling committees, ensure timely updates post-approval, and maintain compliance with global labeling regulations
Ensure compliance with all post-marketing commitments, periodic safety updates, and pharmacovigilance reporting requirements
Partner with Clinical Development, CMC, Pharmacovigilance, and Commercial to integrate regulatory considerations into development and launch strategies
Provide regulatory insight during portfolio prioritization, licensing, and business development activities
Lead and mentor a high-performing regulatory team, fostering professional growth and operational excellence
Represent TG Therapeutics in high-level agency meetings, including FDA Advisory Committees and labeling negotiations
Maintain awareness of evolving global regulatory guidance and ensure alignment with best practices
Cultivate relationships with external partners, CROs, and regulatory consultants to expand organizational capabilities
Qualification
Required
15+ years of regulatory affairs experience in the biotech or pharmaceutical industry, with a minimum of 5 years in senior leadership roles
Demonstrated success in leading global submissions and securing product approvals
Expertise in U.S. FDA regulatory requirements; strong working knowledge of EMA and other global health authority processes
Proven experience leading label development, negotiation, and lifecycle management for approved products
Experience with product launches, labeling negotiations, and regulatory interactions at the highest levels
Proven ability to lead complex projects and influence cross-functional and executive teams
An advanced degree in life sciences (MD, PhD, PharmD, or MS)
Company
TG Therapeutics, Inc.
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.
201-500 employees
H1B Sponsorship
TG Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
Funding
Current Stage
Public CompanyTotal Funding
$455MKey Investors
Hercules Capital
2024-08-06Post Ipo Debt· $250M
2022-01-04Post Ipo Debt· $70M
2019-12-24Post Ipo Equity· $50M
Leadership Team
M
Mark Glick
VP Program Management
Recent News
2026-01-16
Company data provided by crunchbase