Manager​/Sr. Manager, Regulatory Submissions

Title:
Manager/Senior Manager, Regulatory Submissions

Location:
Remote

TG Therapeutics is a fully integrated, commercial stage, biotechnology 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 Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features.

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We are seeking a motivated and detail-oriented Regulatory Operations professional to join our Regulatory Affairs team and report to the Associate Director, Global Regulatory Affairs. The successful candidate will play a essential role in planning, preparing, and submitting global regulatory applications, including Investigation New Drug Applications (INDs), global clinical trial applications, and Biologics License Applications (BLAs) across multiple clinical programs.

This role will collaborate closely with cross-functional teams, including Regulatory Affairs, CMC, and Clinical, to ensure timely, accurate, and compliant submissions that support the company’s product development and commercialization goals.

• Plan, compile, and publish regulatory submissions (e.g., INDs, CTRs, BLAs, amendments, supplements, briefing packages) in eCTD format in accordance with global health authority requirements
• Serve as submission lead for major applications, managing timelines and coordinating with internal contributors and external vendors
• Support lifecycle management of existing submissions, ensuring accuracy, compliance, and version control across all modules
• Maintain submission tracking systems and ensure completeness and consistency across documents and metadata
  
  Coordinate third‑party interactions with health authority portals (e.g., FDA ESG) and troubleshoot submission issues as needed
• Ensure compliance with current regulatory standards, including ICH, FDA, and EMA eCTD specifications
• Participate in the development and maintenance of Regulatory Operations SOPs and templates

• Experience with Clinical Trial Applications (CTR) in the EU or other global territories; CTIS experience highly preferred
• Knowledge of global submission pathways and regional differences in electronic requirements
• Experience with Veeva Vault RIM
• Strong project management skills and ability to maintain oversight of multiple complex and fast‑moving programs

• 3+ years of hands‑on experience in Regulatory Operations within the biotech or pharmaceutical industry.
• Proven experience leading or supporting IND submissions and CTR applications from planning through submission and approval
• Strong working knowledge of eCTD publishing tools and regulatory requirements (FDA, EMA, ICH)
• Proficiency in document formatting and lifecycle management systems (e.g., Veeva Vault RIM)
• Strong attention to detail, organization, and communication skills

• Bachelor’s degree in life sciences or related field (advanced degree a plus)

Applicants must be currently authorized to work in the United States on a full‑time basis. The company does not sponsor employment visas for this position.

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.