Director, Biologics CMC Writing & Strategy

Travere Therapeutics; Kansas City (MO); On-site; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. This role collaborates across Regulatory Affairs, QA, Manufacturing, and external partners to deliver regulator-ready narratives.

The ideal candidate has 10+ years in pharma/biotech, with expertise in biologics development, fermentation, and device-related considerations.

Qualifications

• 10+ years of pharmaceutical/biotech industry experience.
• Experience authoring CTD Module 2 and Module 3 content for BLA or late-stage biologics.
• Experience with microbial fermentation, recombinant proteins, or bacterial expression systems.
• Strong knowledge of biologics development, manufacturing, analytics, and stability.
• Experience with FDA meetings, regulatory information requests, or pre-approval inspections.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions.
• Translate complex technical data into regulator-ready narratives.
• Develop document strategies, content plans, timelines, templates, and authoring standards for the CMC submission.
• Author and coordinate sections covering drug substance/product manufacturing processes, validation, and control strategies.
• Ensure consistency across Module 3 sections and alignment with governance and data.
• Lead cross-functional authoring and decision-making forums and drive timely resolution of gaps.
• Identify submission risks and data gaps early in the process.
• Manage reviews, comment resolution, version control, and approvals.
• Prepare PowerPoint presentations for governance meetings and regulatory interactions.

Skills

Regulatory writing

Scientific writing

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree

MS/PhD preferred

Tools

PowerPoint

Job description

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. This role collaborates across Regulatory Affairs, QA, Manufacturing, and external partners to deliver regulator-ready narratives.

The ideal candidate has 10+ years in pharma/biotech, with expertise in biologics development, fermentation, and device-related considerations.