Manager/Senior Manager, Regulatory Submissions

TG Therapeutics, Inc.; United States; Vor Ort; USD 100.000 - 180.000; Vollzeit

Zusammenfassung

TG Therapeutics, Inc. seeks a Regulatory Operations professional to join the Regulatory Affairs team.

The role focuses on planning, preparing, and submitting global regulatory applications (INDs, CTRs, BLAs) across multiple programs, coordinating with cross-functional teams to ensure timely, compliant submissions. You will lead eCTD publishing, manage submission timelines, and maintain document control and SOPs, with emphasis on FDA/EMA guidelines.

Qualifikationen

• 5+ years in Regulatory Operations within biotech/pharma.
• Experience leading or supporting IND submissions from planning to approval.
• Knowledge of FDA/EMA/ICH regulatory requirements and eCTD.
• Strong attention to detail and communication skills.

Aufgaben

• Plan, compile, and publish regulatory submissions (INDs, CTRs, BLAs) in eCTD format.
• Serve as submission lead, managing timelines and coordinating contributors.
• Support lifecycle management and document/version control across modules.
• Coordinate interactions with health authority portals and troubleshoot issues.
• Maintain submission tracking systems and ensure compliance with SOPs.

Kenntnisse

Regulatory submissions

IND/CTR submissions

eCTD publishing

Project management

Ausbildung

Bachelor's degree in life sciences

Tools

Veeva Vault RIM

Jobbeschreibung

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) in the US and European Commission.

Position:

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.

Key Responsibilities:

• 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

Preferred qualifications:

• 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

Qualifications:

• 5+ 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

Education:

• 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.