Director, Biologics CMC Writing & Regulatory Strategy (Remote)
Travere Therapeutics
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Job summary
Travere Therapeutics in San Diego, CA is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead CMC documentation for regulatory submissions. The role emphasizes drafting Module 3 sections, writing drug substance/product manufacturing content, and coordinating cross-functional teams to ensure regulator-ready narratives.
The ideal candidate has deep experience with biologics, microbial systems, and device-related components, plus strong PowerPoint and regulatory
Qualifications
- 10+ years of progressively relevant pharmaceutical/biotech experience.
- 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, analytical control, and process validation.
Responsibilities
- Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
- Translate complex technical data into regulator-ready narratives.
- Develop content strategies, timelines, and authoring standards for CMC submission.
- Coordinate sections covering drug substance/product manufacturing, process development, characterization and control strategies, and stability programs.
Skills
Education
Tools
Job description
Travere Therapeutics in San Diego, CA is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead CMC documentation for regulatory submissions. The role emphasizes drafting Module 3 sections, writing drug substance/product manufacturing content, and coordinating cross-functional teams to ensure regulator-ready narratives.
The ideal candidate has deep experience with biologics, microbial systems, and device-related components, plus strong PowerPoint and regulatory
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