Global Regulatory Submissions Lead (IND/CTR/BLAs)

TG Therapeutics, Inc.; United States; On-site; USD 100,000 - 180,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory submissions

IND/CTR submissions

eCTD publishing

Project management

Education

Bachelor's degree in life sciences

Tools

Veeva Vault RIM

Job description

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.