Biologics CMC Lead: Regulatory Writing Director

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

Job summary

Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) in San Diego. You will lead the preparation of CMC documentation for regulatory submissions, including BLA, and drive the strategy and execution of Module 3 content for biologics products.

The role requires extensive CTD experience, collaboration across Regulatory Affairs, QA, Manufacturing, and external partners, and strong scientific writing abilities.

Qualifications

• 10+ years in pharma/biotech with CTD Module 2/3 experience.
• Direct experience authoring CTD Module 2 and Module 3 content for BLA or similar submission.
• Experience with biologics development, manufacturing, and regulatory sciences.

Responsibilities

• Lead the planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
• Coordinate sections covering drug substance/product manufacturing, process development, validation, and control strategies.
• Prepare and align Module 3 content with QA, regulatory, and governance requirements.
• Collaborate with regulatory affairs, SMEs, and external partners to resolve content gaps.
• Prepare governance presentations and regulatory responses as needed.
• Manage document reviews, version control, and approval workflows.

Skills

Regulatory writing

Cross-functional collaboration

Regulatory strategy

Strong writing skills

PowerPoint presentations

Attention to detail

Education

Bachelor's degree in pharmaceutical sciences/related field

MS/PhD preferred

Tools

Microsoft PowerPoint

eCTD tools

Job description

Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) in San Diego. You will lead the preparation of CMC documentation for regulatory submissions, including BLA, and drive the strategy and execution of Module 3 content for biologics products.

The role requires extensive CTD experience, collaboration across Regulatory Affairs, QA, Manufacturing, and external partners, and strong scientific writing abilities.