Director, Biologics CMC Technical Writing (Remote)

Travere Therapeutics; Boston (MA); Remote; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and 3 content for regulatory submissions, including BLA. The role requires strong scientific judgment, superb writing, and collaboration across Regulatory Affairs, Quality, Manufacturing, and external partners.

The ideal candidate has 10+ years in pharma/biotech with CTD modules experience, especially in biologics, and must be able to travel up to 10%.

Qualifications

• 10+ years in pharma/biotech; CTD Module 2/3 authoring for a BLA or equivalent.
• Experience with biologics development, manufacturing, and analytical control.
• Strong scientific judgment and exceptional writing ability.

Responsibilities

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

Skills

Regulatory writing

Cross-functional leadership

Strategic thinking

PowerPoint

Education

Bachelor's degree

MS/PhD preferred

Job description

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and 3 content for regulatory submissions, including BLA. The role requires strong scientific judgment, superb writing, and collaboration across Regulatory Affairs, Quality, Manufacturing, and external partners.

The ideal candidate has 10+ years in pharma/biotech with CTD modules experience, especially in biologics, and must be able to travel up to 10%.