Remote Director, Biologics CMC & Regulatory Writing

Travere Therapeutics

Denver (CO)

Hybrid

USD 189,000 - 246,000

Full time

6 days ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

Travere Therapeutics in San Diego, with remote flexibility, is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and Module 3 content for regulatory submissions, including BLA, in collaboration with Regulatory Affairs and external partners.

The role requires 10+ years in pharma/biotech, deep biologics know-how, strong writing, and ability to drive cross-functional decisions.

Qualifications

10+ years of pharmaceutical/biotech experience.
Direct experience authoring CTD Module 2 and Module 3 content for at least one BLA or late-stage biologics submission.
Strong writing, regulatory interactions, and cross-functional collaboration skills.

Responsibilities

Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA) including CTD Module 2 summaries and Module 3 sections.
Translate complex technical data into regulator-ready narratives.
Develop document strategies, content plans, timelines, templates, and authoring standards for the CMC submission.
Author and coordinate sections on drug substance/product manufacturing, process development, characterization, validation, control strategies, and stability.
Ensure consistency across Module 3 sections and alignment with regulatory strategy and data.
Lead cross-functional forums and drive timely resolution of technical or content gaps.
Identify submission risks and data gaps early in authoring.
Manage document reviews, version control, and approval workflows.
Support FDA information requests during BLA review.
Prepare governance presentations for regulatory interactions and executive updates.
Establish sustainable CMC authoring best practices.