Director, Biologics CMC Technical Writing - Remote

Travere Therapeutics; Providence (RI); Remote; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health benefits

401(k) with company match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. You will coordinate cross-functional teams and drive regulator-ready narratives that communicate development history, manufacturing, and control strategy.

The role requires extensive biologics expertise, strong writing skills, and the ability to influence SMEs, Regulatory Affairs, and QA across San

Qualifications

• Bachelor's degree in pharmaceutical sciences, chemical engineering, biotechnology, or related discipline.
• 10+ years of pharmaceutical/biotechnology industry experience with CTD Module 2 and Module 3 content for at least one BLA or comparable submission.
• Strong knowledge of biologics development, manufacturing, analytical control, process validation, and scale-up.

Responsibilities

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

Skills

Regulatory writing

Cross-functional leadership

Technical leadership

Project management

PowerPoint expertise

Education

Bachelor's degree in pharmaceutical sciences or related

M.S. or Ph.D. preferred

Tools

PowerPoint

Job description

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. You will coordinate cross-functional teams and drive regulator-ready narratives that communicate development history, manufacturing, and control strategy.

The role requires extensive biologics expertise, strong writing skills, and the ability to influence SMEs, Regulatory Affairs, and QA across San