Research & Development Associate

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 approval from the United States Food and Drug Administration (FDA) 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, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in New York City, New Jersey, and Raleigh, NC.

Position:

We are seeking a dynamic and proactive Research and Development Associate to join our Regulatory Affairs team. This role will be instrumental in supporting the various aspects of product development including nonclinical and clinical research. The ideal candidate will have a strong life sciences background, with a passion to build a career in the pharmaceutical industry. We are looking for a highly motivated individual, who can be a team player and an independent thinker. This role will report to the Associate Director, Regulatory and Development Strategy.

Key Responsibilities:

• Collaborate with cross-functional teams to develop and implement regulatory strategies for product development programs
• Assist in the preparation and submission of regulatory documents, including INDs, NDAs, and MAAs, in alignment with development timelines and strategic objectives
• Provide regulatory guidance and support to internal stakeholders, including R&D, clinical, and manufacturing teams, to ensure compliance with regulatory requirements throughout the product lifecycle
• Conduct regulatory assessments to evaluate the impact of new regulations or changes on development plans and recommend appropriate actions
• Support oversight of nonclinical studies including toxicology evaluations
• Support oversight of clinical pharmacology activities as needed/assigned
• Provide regulatory guidance and support to internal stakeholders, including R&D, clinical, and manufacturing teams, to ensure compliance with regulatory requirements throughout the product lifecycle
• Contribute to the development of regulatory submission plans and timelines, ensuring alignment with development milestones and strategic goals
• Participate in regulatory agency interactions, including pre-submission meetings and regulatory submissions, to facilitate product approvals and regulatory compliance

Qualifications:

• Understanding of regulatory submissions preferably for biologics or advanced therapy medicinal products
• Laboratory research experience, preferred
• Familiarity with Microsoft Office suite

Education:

• BS/BA degree in a scientific discipline (e.g. biology, genetics, neuroscience, biotechnology, biochemistry, etc.)
• MS/MA/PhD. degree a plus

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.