Director, Biologics CMC Technical Writing - Remote

Travere Therapeutics; San Diego (CA); On-site; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics is seeking a Director of Technical Operations to lead CMC content for regulatory submissions, including BLA. The role requires extensive experience authoring Module 3 content for biologics and strong collaboration with Regulatory Affairs, Quality, and Manufacturing to ensure submission readiness.

The ideal candidate will have 10+ years in pharma/biotech, expertise in biologics development and process validation, and the ability to drive decisions across SMEs and external

Qualifications

• Bachelor's degree required in pharmaceutical sciences, chemical engineering, biotechnology, or related field.
• 10+ years of pharma/biotech industry experience, CTD Module 2 & 3 authoring for at least one BLA or late-stage submission.
• Experience with biologics development, manufacturing, process validation, and regulatory submissions.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
• Translate technical data into regulator-ready narratives.
• Develop content plans, templates, and authoring standards for CMC submissions.
• Coordinate sections on drug substance/product manufacturing, process development, characterization, and control strategies.
• Ensure consistency across Module 3 and alignment with regulatory strategy and data.

Skills

Biologics CTD Module 2/3

Regulatory writing

Regulatory strategy

Cross-functional leadership

PowerPoint presentations

FDA interactions experience

Education

Bachelor's degree in pharmaceutical sciences/chemistry/biotechnology

MS or PhD preferred

Job description

Travere Therapeutics is seeking a Director of Technical Operations to lead CMC content for regulatory submissions, including BLA. The role requires extensive experience authoring Module 3 content for biologics and strong collaboration with Regulatory Affairs, Quality, and Manufacturing to ensure submission readiness.

The ideal candidate will have 10+ years in pharma/biotech, expertise in biologics development and process validation, and the ability to drive decisions across SMEs and external