Associate Director, CMC Regulatory Affairs – Small Molecules

Travere Therapeutics

. Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management of small molecule products .

Posted 9/30/2026full-timeSan Diego • California • United StatesSenior💰 $150,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in developing and implementing global CMC regulatory strategies for small molecule products, with a strong focus on regulatory submissions and lifecycle management. Proven ability to lead cross-functional teams and ensure compliance with regulatory requirements throughout product development and commercialization.

Highest-signal resume keywords

CMC Regulatory AffairsGlobal Regulatory SubmissionsIND Through NDA ApprovalSmall Molecule Pharmaceutical ProductsHealth Authority Interactions

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentCMC Documentation AuthoringFormulation DevelopmentProcess ValidationAnalytical Method DevelopmentRegulatory Risk AssessmentLifecycle ManagementManufacturing Process DevelopmentGlobal Regulatory CompliancePost-Approval CMC Changes

Soft Skills

Leadership CapabilitiesRelationship BuildingIndependent WorkStrategic Guidance

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryFDAEMAGCC Regulatory AuthoritiesPMDAOral Solid Dosage FormsINDsCTAsMAAs

About the role

Key responsibilities & impact

Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management of small molecule products
Serve as CMC Regulatory lead on cross-functional program teams
Provide strategic regulatory guidance throughout product development and commercialization
Partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management
Assess regulatory risks, develop mitigation strategies, and provide regulatory recommendations
Support products from IND through NDA approval and post-approval lifecycle management
Lead preparation, review, and submission of global CMC filings, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, variations, annual reports, and Health Authority responses
Author and review Module 2 and Module 3 CMC documentation
Coordinate cross-functional contributions and ensure regional regulatory compliance
Represent CMC Regulatory Affairs in Health Authority meetings and responses
Support inspection readiness and regulatory assessments related to manufacturing, quality systems, and product quality
Develop filing strategies for post-approval CMC changes
Guide formulation development, process development, scale-up, technology transfer, process validation, and commercial manufacturing
Evaluate regulatory impacts of APIs, excipients, formulations, manufacturing processes, packaging systems, and manufacturing sites
Provide oversight for analytical method development, validation, specifications, and stability programs
Contribute to assessments of CMAs, CPPs, CQAs, control strategies, and pharmaceutical development
Support combination product or biologic product regulatory activities when applicable

Requirements

What you’ll need

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline required
Equivalent combination of education and applicable job experience may be considered
8+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry, including significant CMC Regulatory Affairs experience
Strong experience with small molecule pharmaceutical products from IND through commercialization and post-approval lifecycle management required
Extensive experience supporting oral solid dosage forms, including tablets, capsules, and related drug product manufacturing
Demonstrated experience preparing and managing global CMC regulatory submissions, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, annual reports, and variations
Experience supporting global regulatory activities with FDA, EMA, GCC regulatory authorities, and PMDA
Experience supporting manufacturing process development, formulation development, process validation, technology transfer, and commercialization of small molecule drug products
Experience leading or supporting Health Authority interactions related to CMC topics
Demonstrated experience managing post-approval CMC changes, including manufacturing changes, site transfers, specification updates, analytical method changes, supplier changes, and lifecycle management activities
Ability to work independently and take ownership of complex CMC regulatory activities
Demonstrated leadership capabilities and ability to build effective relationships with internal and external stakeholders
Ability to travel 10% domestically and internationally

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 (company stock)