Director, Biologics CMC Technical Writing

Travere Therapeutics

. Lead planning, authoring, and delivery of CMC content for regulatory submissions such as BLAs, including CTD Module 2 summaries and Module 3 sections .

Posted 9/30/2026full-timeSan Diego • California • United StatesLead💰 $189,000 - $246,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in authoring CMC content for regulatory submissions, including CTD Module 2 and Module 3, with a strong focus on biologics development and manufacturing processes. Proven ability to translate complex technical data into clear narratives and manage cross-functional collaboration for successful regulatory interactions.

Highest-signal resume keywords

CTD Module 2 AuthoringCTD Module 3 AuthoringBiologics DevelopmentMicrobial FermentationRegulatory Submission Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsDocument StrategiesProcess ValidationAnalytical ControlManufacturing SpecificationsLyophilizationComparabilityStability StudiesTechnical WritingContent Planning

Soft Skills

Cross-Functional CollaborationProblem SolvingCommunicationDecision MakingLeadership

Tools & Technologies

PowerPointDocument Management SystemsRegulatory Information Systems

Industry Keywords

Pharmaceutical SciencesBiotechnologyBLA ReviewFDA InteractionsCombination ProductsDevice Risk Management

About the role

Key responsibilities & impact

Lead planning, authoring, and delivery of CMC content for regulatory submissions such as BLAs, including CTD Module 2 summaries and Module 3 sections
Translate complex technical data into clear, concise, accurate, regulator-ready narratives
Develop document strategies, content plans, timelines, templates, and authoring standards for CMC submissions
Author and coordinate sections covering drug substance and drug product manufacturing, process development, characterization, validation, control strategies, fermentation, purification, specifications, analytical procedures, formulation, lyophilization, container closure, stability, comparability, and lifecycle changes
Ensure consistency across Module 3 sections and alignment with regulatory strategy, source reports, and supporting data
Lead cross-functional authoring and decision-making forums
Reconcile differing technical perspectives and establish key regulatory messages
Drive timely resolution of technical and content gaps
Identify submission risks, data gaps, inconsistencies, and potential regulatory questions
Manage document reviews, comment resolution, version control, and approval workflows
Support responses to FDA information requests and other regulatory questions during BLA review
Collaborate with internal teams, contract manufacturers, testing laboratories, consultants, and external partners
Prepare PowerPoint presentations for governance meetings, regulatory interactions, technical reviews, and executive updates
Establish sustainable CMC authoring best practices
Perform additional duties as needed

Requirements

What you’ll need

Bachelor’s degree in pharmaceutical sciences, chemical engineering, biotechnology, or a related discipline required
Equivalent combination of education and applicable job experience may be considered
10+ years of progressively relevant pharmaceutical or biotechnology industry experience required
Direct experience authoring CTD Module 2 and Module 3 content for at least one BLA, marketing application, or comparable late-stage biologics submission
Strong working experience with microbial fermentation, recombinant proteins, or bacterial expression systems required
Strong knowledge of biologics development, manufacturing, analytical control, process validation, scale up, comparability, stability, and commercial manufacturing
Experience participating in FDA meetings, BLA review activities, regulatory information requests, or pre-approval inspections
Experience with delivery systems, design controls, human factors activities, and device-related risk management
Advanced PowerPoint skills and experience preparing technical, regulatory, governance, and executive-level presentations
Ability to travel 10% domestically and internationally
Ability to perform face-to-face work with colleagues and/or onsite in San Diego
M.S., Ph.D., or other relevant advanced degree preferred
Experience with lyophilized drug product, combination products, and device constituent components highly desirable

Benefits

Comp & perks

Premium health, financial, work-life and well-being offerings for eligible employees and dependents
Wellness and employee support programs
Life insurance
Disability benefits
Retirement plans with employer match
Generous paid time off
Short-term incentive
Long-term incentive compensation in company stock
Reasonable accommodation for the application, interview, or hiring process