Director, Biologics CMC Technical Writing – Regulatory Submissions

Travere Therapeutics; Detroit (MI); On-site; USD 189,000 - 246,000; Full time

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 guide the strategy in collaboration with Regulatory Affairs and SMEs, directing high-quality, regulator-ready content that communicates development history, manufacturing process, and control strategy.

The ideal candidate has extensive experience authoring Module 3 content for biologics, with strong

Qualifications

• Bachelor's degree in pharmaceutical sciences, chemical engineering, biotechnology, or related field; equivalent experience considered.
• 10+ years of pharmaceutical/biotech experience; CTD Module 2/3 content for BLA or comparable submission.
• Experience authoring CTD Module 2 and Module 3 for biologics; strong knowledge of biologics development and manufacturing.
• Strong writing, regulatory, and cross-functional collaboration skills.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
• Translate complex technical data into regulator-ready narratives.
• Develop document strategies, content plans, timelines, and templates for CMC submission.
• Coordinate sections on drug substance/product manufacturing, process development, and control strategies.
• Create and align Module 3 content with QOS, regulatory strategy, and supporting data.
• Lead cross-functional authoring forums and drive timely resolution of gaps.
• Identify data gaps and regulatory questions early in the authoring process.
• Manage reviews, approvals, and version control; support FDA inquiries.
• Collaborate with internal teams, contract manufacturers, labs, and consultants.
• Prepare governance-ready PowerPoint presentations for regulatory interactions.

Skills

Regulatory writing

Biologics CMC

Cross-functional collaboration

Regulatory meetings

PowerPoint presentations

Education

Bachelor's degree in pharmaceutical sciences/chemical engineering/biotechnology

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 guide the strategy in collaboration with Regulatory Affairs and SMEs, directing high-quality, regulator-ready content that communicates development history, manufacturing process, and control strategy.

The ideal candidate has extensive experience authoring Module 3 content for biologics, with strong