Director, Biologics CMC Regulatory Writing

Travere Therapeutics; New York (NY); Remote; USD 189,000 - 246,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of regulatory CMC documentation, including BLA submissions. You will drive the strategy with Regulatory Affairs and SMEs, delivering rigorous, regulator-ready content that communicates development history, manufacturing process, control strategy, and commercial readiness.

The ideal candidate has extensive experience authoring Module 3 content for biologics, strong scientific

Qualifications

• Bachelor's degree in pharmaceutical sciences, chemical engineering, biotechnology, or related field required.
• MS/PhD or equivalent preferred.
• 10+ years of relevant pharmaceutical/biotech experience; CTD Module 2/3 for at least one BLA or late-stage biologics submission.
• Experience with biologics development, manufacturing, analytical control, process validation, scale-up, and stability.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA), including CTD Module 2 summaries and Module 3 sections.
• Translate complex data into regulator-ready narratives.
• Develop document strategies, content plans, timelines, and authoring standards.
• Coordinate sections on drug substance/product manufacturing, process development, characterization, validation, control strategies, and formulation development.
• Ensure consistency across Module 3 with QA summaries, regulatory strategy, and data.

Skills

Regulatory writing

Biologics CMC

Cross-functional collaboration

Advanced PowerPoint

Microsoft Office

Education

Bachelor's degree in pharmaceutical sciences or related

MS/PhD preferred

Tools

PowerPoint

Microsoft Office

Job description

Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of regulatory CMC documentation, including BLA submissions. You will drive the strategy with Regulatory Affairs and SMEs, delivering rigorous, regulator-ready content that communicates development history, manufacturing process, control strategy, and commercial readiness.

The ideal candidate has extensive experience authoring Module 3 content for biologics, strong scientific