Senior Manager, CMC Regulatory Affairs (Biologics)

Senior Manager, CMC Regulatory Affairs Department: 107000 | Location: San Diego, USA – Remote (no role is 100% remote) Position Summary: The Senior Manager, CMC Regulatory Affairs provides strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls activities across development and commercial programs. The role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management for biologic products, particularly late‑stage Phase3 programs and rare disease therapeutics. The Senior Manager is the primary CMC regulatory representative on cross‑functional teams and partners closely with Technical Operations, Process Development, Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to align CMC plans with global regulatory requirements and business objectives. Extensive experience supporting biologics development programs and a strong technical understanding of biologic drug substance and product manufacturing, analytical characterization, process development, comparability, and control strategies are required. Responsibilities Develop and implement global CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of biologic products. Serve as CMC regulatory lead on cross‑functional program teams, providing strategic regulatory guidance throughout product development. Assess regulatory risks, develop mitigation strategies, and provide regulatory recommendations to support program goals and business priorities. Contribute to regulatory strategy development for expedited programs, orphan drug products, and rare disease indications. Lead preparation, review, and submission of CMC documentation for global regulatory filings, including INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, and annual reports. Author and review Module2 and Module3 content and ensure consistency across submission components. Coordinate cross‑functional contributions to CMC regulatory submissions and ensure compliance with global regulatory requirements and submission standards. Support preparation for major registration milestones, including first marketing applications and global expansion filings. Lead CMC‑related Health Authority interactions and support agency meetings globally. Support inspection readiness and regulatory assessments related to manufacturing and product quality. Develop global regulatory filing strategies for lifecycle management activities and post‑approval CMC changes, including manufacturing process changes, analytical method updates, specification revisions, site transfers, process validation, and comparability assessments. Provide regulatory guidance and strategic input for biologics development programs, including monoclonal antibodies, recombinant proteins, fusion proteins, and other complex biologic modalities. Collaborate with development and manufacturing teams to support regulatory strategies related to cell line development, upstream and downstream process development, scale‑up, process validation, and commercial manufacturing. Evaluate regulatory impact of manufacturing changes involving microbial and mammalian cell culture processes, purification operations, formulation development, fill‑finish activities, and technology transfers. Support development and regulatory assessment of comparability strategies for manufacturing process changes, site transfers, process improvements, and lifecycle management activities. Provide regulatory oversight and strategic guidance for analytical characterization programs and control strategies supporting product quality, safety, and efficacy. Contribute to regulatory assessment of critical quality attributes (CQAs), process parameters, control strategies, and product characterization data throughout development and commercialization. Education & Experience Requirements Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required. Advanced degree (MS, PharmD, PhD, or equivalent) preferred. 7+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry, including significant CMC Regulatory Affairs experience. Demonstrated experience supporting biologics development programs from early development through commercialization. Significant experience supporting Phase3 and late‑stage development programs. Experience supporting global regulatory submissions, including BLAs, MAAs, NDAs, INDs, IMPDs, and CTAs. Extensive experience leading CMC regulatory activities for biologic products, particularly monoclonal antibodies, recombinant proteins, and other therapeutic biologics. Experience supporting manufacturing process development and commercialization of biologic drug substances and drug products. Experience participating in and leading Health Authority interactions related to CMC topics. Experience supporting global post‑approval change management, comparability assessments, process validation, and lifecycle management activities. Additional Skills & Experience Comprehensive understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC regulatory requirements. Strong understanding of biologics regulatory requirements throughout product development and commercialization. Experience supporting products for rare diseases and/or orphan indications preferred. Demonstrated ability to develop and execute global CMC regulatory strategies. Strong knowledge of CMC development, process validation, comparability, quality systems, and lifecycle management requirements. Strong technical understanding of biologics drug substance manufacturing processes and downstream processing and purification technologies. Strong understanding of biologic drug product development including analytical methods and characterization techniques used for biologics. Strong understanding of critical quality attributes (CQAs), quality target product profiles (QTPPs), control strategies, and analytical comparability principles for monoclonal antibodies and recombinant protein therapeutics. Ability to travel up to 10% domestically and internationally. All positions have an essential job function to be able to perform face‑to‑face work with colleagues and/or onsite in San Diego. Benefits Comprehensive total rewards offerings include premium health, financial, work‑life and well‑being programs, life insurance, disability, retirement plans with employer match, and generous paid time off. Compensation Target base pay range: $132,000.00 – $172,000.00. Compensation may be modified based on experience, education, skills, and location. Base pay is combined with short‑term and long‑term incentive compensation. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer. All positions have an essential job function to perform face‑to‑face work. If you require a reasonable accommodation to complete the application or interview process, please contact View email address on click.appcast.io. #J-18808-Ljbffr Travere