TG Therapeutics, Inc.
Senior Director, Head of Regulatory Affairs
TG Therapeutics, Inc., Raleigh, North Carolina, United States
Senior Director, Head of Regulatory Affairs
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 approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab‑xiiy) in the US and European Commission.
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 with 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.
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.
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.
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.
Education
An advanced degree in life sciences (MD, PhD, PharmD, or MS).
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.
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
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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 with 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.
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.
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.
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.
Education
An advanced degree in life sciences (MD, PhD, PharmD, or MS).
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.
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Get notified about new Head of Regulatory Affairs jobs in North Carolina, United States.
#J-18808-Ljbffr