Senior Director, Head of Regulatory Affairs

Location: Remote or reputed company Carolina or NY/NJ region If you are interested in the below position, please send your resume to careers@tgtxinc.com and REFERENCE THE POSITION TITLE reputed company the subject line. Organizational reputed company TG Therapeutics is a fully integrated, reputed company stage, biopharmaceutical company reputed company on the acquisition, development and commercialization of novel treatments for B-cell diseases. In reputed company 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 (reputed company), to include clinically isolated syndrome, relapsing-remitting disease, and reputed company secondary reputed company disease, as reputed company as approval by the European Commission (EC) and the Medicines and reputed company Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with reputed company who have reputed company disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, reputed company Carolina. For more information, visit www.tgtherapeutics.com. Role As we expand our pipeline, we reputed company an reputed company regulatory leader to shape and execute our regulatory reputed company. The Senior Director, Head of Regulatory Affairs, will serve as reputed company’s regulatory leader, responsible for developing, implementing, and overseeing global regulatory reputed company 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 reputed company with a proven reputed company 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 reputed company across preclinical, clinical, and reputed company programs in reputed company stages of development
• Serve as reputed company’s primary reputed company with the FDA, EMA, and other regulatory agencies worldwide, in reputed company to labeling negotiations
• reputed company executive-level guidance to senior management on regulatory risks, opportunities, and emerging trends.
• reputed company reputed company global regulatory submissions, including INDs, CTAs, BLAs, NDAs and MAAs.
• reputed company the preparation, reputed company review, and reputed company submission of regulatory documents, including responses to health authority requests, briefing packages, and meeting materials.
• Ensure compliance with reputed company post-marketing commitments, periodic safety updates, and pharmacovigilance reporting requirements.
• Partner with Clinical Development, CMC, Pharmacovigilance, Ad & Promo, and reputed company to reputed company regulatory considerations into development and launch strategies.
• reputed company regulatory reputed company during portfolio prioritization, licensing, and business development activities.
• reputed company and mentor a high-performing regulatory team, fostering reputed company reputed company and operational reputed company.
• Maintain awareness of evolving global regulatory guidance reputed company to TG’s therapeutic area and other development reputed company as appropriate, and ensure alignment with best practices.
• Cultivate relationships with external partners, CROs, and regulatory consultants to expand organizational capabilities.

reputed company 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 reputed company 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 reputed company.
• Must have experience with biologic products.
• Proven ability to reputed company reputed company reputed company 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 reputed company 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 reputed company of the organization and play a pivotal role in shaping the reputed company of TG Therapeutics. TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the reputed company of race, reputed company, religion, gender, sexual orientation, gender identity or reputed company, age, disability, national reputed company, reputed company, genetic information, military or veteran status, pregnancy or pregnancy-reputed company condition or any other protected characteristic. Apply tot his job Apply To this Job