Remote Director, Biologics CMC Technical Writing

Travere Therapeutics; Columbia (SC); On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health benefits

Stock options/long-term incentive

Job summary

Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. You will drive strategy with SME teams, author Module 3 content for biologics, and communicate development history, manufacturing process, control strategy, and readiness for market.

The role requires extensive CTD Module 3 experience, strong scientific writing, and collaboration with Regulatory Affairs,

Qualifications

• Direct experience authoring CTD Module 2 and Module 3 content for at least one BLA or late-stage biologics submission.
• Strong knowledge of biologics development, manufacturing, and analytical control.
• Experience with regulatory interactions and cross-functional teams.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
• Translate complex data into regulator-ready narratives.
• Develop content plans, templates, and standards for CMC submission.
• Coordinate sections on drug substance/product manufacturing, process development, characterization, and control strategies.
• Ensure consistency of Module 3 with regulatory strategy and supporting data.
• Lead cross-functional discussions and drive timely resolution of gaps.
• Prepare governance materials and presentations for regulatory meetings.

Skills

CTD Module 2/3

Biologics development

Regulatory writing

Cross-functional collaboration

Regulatory submissions

FDA meetings

Education

Bachelor's degree in pharmaceutical sciences/related

MS or PhD preferred

Tools

PowerPoint

Job description

Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. You will drive strategy with SME teams, author Module 3 content for biologics, and communicate development history, manufacturing process, control strategy, and readiness for market.

The role requires extensive CTD Module 3 experience, strong scientific writing, and collaboration with Regulatory Affairs,