Regulatory Submissions Lead: INDs, BLAs & CTRs (Remote)

TG Therapeutics, Inc.; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Manager/Senior Manager of Regulatory Submissions to join our Regulatory Affairs team.

This remote role focuses on planning, preparing, and submitting global regulatory applications, including INDs, CTRs, and BLAs across multiple programs, ensuring timeliness and compliance. You will collaborate with Regulatory Affairs, CMC, and Clinical to coordinate submissions, manage timelines, and maintain submission tracking.

Qualifications

• 3+ years of hands-on Regulatory Operations experience in biotech/pharma.
• Experience leading or supporting IND submissions and CTRs.
• Knowledge of FDA/EMA/ICH regulatory requirements.
• Proficiency with document lifecycle management systems.

Responsibilities

• Plan, compile, and publish regulatory submissions (INDs, CTRs, BLAs) in ICH-compliant eCTD format.
• Serve as submission lead, coordinating timelines and contributors.
• Support lifecycle management and ensure version control across modules.
• Maintain submission tracking and coordinate with health authority portals.
• Ensure compliance with ICH, FDA, and EMA specifications.
• Help develop Regulatory Operations SOPs and templates.

Skills

Regulatory knowledge

Project management

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Tools

Veeva Vault RIM

eCTD publishing tools

Job description

TG Therapeutics, Inc. is seeking a Manager/Senior Manager of Regulatory Submissions to join our Regulatory Affairs team.

This remote role focuses on planning, preparing, and submitting global regulatory applications, including INDs, CTRs, and BLAs across multiple programs, ensuring timeliness and compliance. You will collaborate with Regulatory Affairs, CMC, and Clinical to coordinate submissions, manage timelines, and maintain submission tracking.