Lead Biologics CMC Technical Writing Director (Remote)

Travere Therapeutics; Wichita (KS); On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health

Financial benefits

Work-life programs

Life insurance

Disability insurance

Employer match

Paid time off

Job summary

Travere Therapeutics, located in San Diego with remote flexibility, seeks a Director of Technical Operations (Biologics CMC Technical Writing). You will lead the preparation of CTD Module 2/3 for regulatory submissions, coordinating with Regulatory Affairs, QA, Manufacturing, and external partners.

Strong writing, cross-functional leadership, and biologics experience are essential. This senior role drives strategy, content standards, and timely delivery of regulatory documents, including

Qualifications

• 10+ years in pharma/biotech, CTD Module 2/3 authoring
• Experience with biologics development, manufacturing, analytics
• Experience coordinating cross-functional teams for regulatory submissions

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 authoring standards for CMC submission
• Author sections on drug substance/product, process development, characterization, specs, and stability
• Ensure consistency across Module 3 and alignment with regulatory strategy and data
• Lead cross-functional forums to resolve technical content gaps
• Identify data gaps and submission risks early
• Manage reviews, versioning, and approvals
• Support FDA responses and regulatory questions during review
• Prepare PowerPoint presentations for governance and regulatory updates
• Establish best practices for CMC authoring
• Other duties as needed

Skills

CMC Writing

Regulatory submissions

Biologics

Cross-functional collaboration

PowerPoint proficiency

Education

Bachelor’s in pharmaceutical sciences/related field

MS/PhD preferred

Tools

CTD Module 2/3

MS Word / Document management

Job description

Travere Therapeutics, located in San Diego with remote flexibility, seeks a Director of Technical Operations (Biologics CMC Technical Writing). You will lead the preparation of CTD Module 2/3 for regulatory submissions, coordinating with Regulatory Affairs, QA, Manufacturing, and external partners.

Strong writing, cross-functional leadership, and biologics experience are essential. This senior role drives strategy, content standards, and timely delivery of regulatory documents, including