Director, Biologics CMC Technical Writing — Remote

Travere Therapeutics; Atlanta (GA); Remote; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics in San Diego (remote) is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead preparation of CTD Module 2/3 content for regulatory submissions, including BLA. This role requires deep experience in drug substance production and the ability to guide SMEs, Regulatory Affairs, Quality, and Manufacturing across timelines.

You will translate complex data into regulator-ready narratives, develop content strategies, and maintain consistency across

Qualifications

• 10+ years of progressively relevant pharmaceutical or biotechnology industry experience.
• Direct experience authoring CTD Module 2 and Module 3 for at least one BLA or late-stage biologics submission.
• Strong knowledge of biologics development, manufacturing, analytical control, process validation, scale up, comparability, stability, and commercial manufacturing.

Responsibilities

• Lead 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 that are clear and concise.
• Develop document strategies, content plans, timelines, templates, and authoring standards for CMC submissions.
• Coordinate sections covering drug substance/product manufacturing processes, process development, validation, control strategies, and analytics.
• Ensure consistency across Module 3 and alignment with regulatory strategy and supporting data.
• Lead cross-functional authoring forums, reconcile perspectives, and drive timely content resolutions.
• Identify submission risks and data gaps early and manage reviews and approval workflows.
• Prepare PowerPoint presentations for governance meetings and external/regulatory interactions.

Skills

Regulatory writing

CMC documentation

Biologics

Education

Bachelor's in pharmaceutical sciences

MS/PhD preferred

Tools

PowerPoint

Regulatory databases

Job description

Travere Therapeutics in San Diego (remote) is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead preparation of CTD Module 2/3 content for regulatory submissions, including BLA. This role requires deep experience in drug substance production and the ability to guide SMEs, Regulatory Affairs, Quality, and Manufacturing across timelines.

You will translate complex data into regulator-ready narratives, develop content strategies, and maintain consistency across