Director, Biologics CMC Technical Writing – Remote

Travere Therapeutics

Manchester (NH)

On-site

USD 189,000 - 246,000

Full time

6 days ago

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Job summary

Travere Therapeutics, a biotechnology company focused on rare diseases, seeks a Director, Technical Operations (Biologics CMC Technical Writing) in San Diego with extensive CTD Module 2/3 experience. The role leads CMC submission strategy, collaborates with Regulatory Affairs and SMEs, and directs preparation of high-quality regulator-ready content for BLA submissions.

The ideal candidate has 10+ years in pharma/biotech, deep knowledge of biologics development, and proven leadership across

Qualifications

10+ years in pharmaceutical/biotech industry
Experience authoring CTD Module 2/Module 3 for at least one BLA or late-stage biologics submission
Strong knowledge of biologics development, manufacturing, analytical control, and stability

Responsibilities

Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA)
Translate complex data into regulator-ready narratives
Develop content plans, timelines, and templates for CMC submissions
Coordinate sections covering drug substance/product manufacturing, process development, characterization, and control strategies
Ensure consistency across Module 3 and alignment with regulatory strategy and data supporting the submission
Lead cross-functional discussions and drive timely resolution of content gaps
Manage reviews, approvals, and response to regulatory information requests