Open Position
Title: Senior Director, Head of Regulatory Affairs
Location: Remote or North Carolina or NY/NJ region
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Organizational Overview
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical 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 has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
As we expand our pipeline, we seek an experienced regulatory leader to shape and execute our regulatory vision. The Senior Director, Head of Regulatory Affairs, will serve as the company’s regulatory leader, responsible for developing, implementing, and overseeing global regulatory strategy across TG Therapeutics’ portfolio. This individual will report directly to the Chief Development Officer and will represent TG Therapeutics to global health authorities.
This role requires a seasoned regulatory affairs professional with a proven track record of successful product development and approvals, deep expertise in U.S. and global regulations, and the ability to influence cross-functional teams and executive decision-making.
Key Responsibilities
–– Define and drive the global regulatory strategy across preclinical, clinical, and commercial programs in all stages of development
–– Serve as the company’s primary liaison with the FDA, EMA, and other regulatory agencies worldwide, in addition to labeling negotiations
–– 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.
–– Ensure compliance with all post-marketing commitments, periodic safety updates, and pharmacovigilance reporting requirements.
–– Partner with Clinical Development, CMC, Pharmacovigilance, Ad & Promo, 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.
–– Maintain awareness of evolving global regulatory guidance related to TG’s therapeutic area and other development projects as appropriate, and ensure alignment with best practices.
–– Cultivate relationships with external partners, CROs, and regulatory consultants to expand organizational capabilities.
Professional Experience/Qualifications
–– 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.
–– Experience with product launches, labeling negotiations, and regulatory interactions at the highest levels.
–– Must have experience with biologic products.
–– Proven ability to lead complex projects and influence cross-functional and executive teams.
Education
– An advanced degree in life sciences (MD, PhD, PharmD, or MS).
Why Join Us? This is a unique opportunity to lead regulatory affairs at a company with a dynamic pipeline and a strong commitment to patients. The Senior Director, Head of Regulatory Affairs will have visibility at the highest levels of the organization and play a pivotal role in shaping the future of TG Therapeutics.
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.