Director, Biologics CMC Technical Writing – Remote
Travere Therapeutics
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Job summary
Travere Therapeutics in San Diego, remote-friendly, seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead CTD Module 2/Module 3 content for regulatory submissions. You will collaborate with Regulatory Affairs, SME teams, and external partners to communicate development history, manufacturing process, control strategy, and readiness for commercialization.
The role requires 10+ years in pharma/biotech, strong writing skills, and ability to drive content decisions across
Qualifications
- 10+ years of experience in pharmaceutical or biotechnology industry, with CTD Module 2/Module 3 authoring experience.
- Strong knowledge of biologics development, manufacturing, analytical control, and process validation.
- Experience with regulatory submissions and cross-functional collaboration across teams.
Responsibilities
- Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
- Translate complex data into regulator-ready narratives for Module 2/Module 3.
- Develop document strategies, content plans, timelines, templates, and standards for CMC submissions.
- Author and coordinate sections covering drug substance/product manufacturing, process development, characterization, and control strategies.
Skills
Education
Job description
Travere Therapeutics in San Diego, remote-friendly, seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead CTD Module 2/Module 3 content for regulatory submissions. You will collaborate with Regulatory Affairs, SME teams, and external partners to communicate development history, manufacturing process, control strategy, and readiness for commercialization.
The role requires 10+ years in pharma/biotech, strong writing skills, and ability to drive content decisions across
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