Senior Manager, CMC Regulatory Affairs (Biologics)

Responsibilities

• CMC Regulatory Strategy, Submissions & Dossier Development
• Develop and implement global CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of biologic products.
• Serve as the 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 development 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 Module 2 and Module 3 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.
• Technical Leadership for Biologics Development
• Provide regulatory guidance and strategic input for biologics development programs, including monoclonal antibodies (mAbs), 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 transfe

Benefits

Additional Information

Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients . Position Summary: The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for biologic products, with a strong focus on late-stage development, Phase 3 programs, and rare disease therapeutics. The Senior Manager serves as the primary CMC Regulatory Affairs 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 ensure alignment of CMC development plans with global regulatory requirements and business objectives. This position requires extensive experience supporting biologics development programs and a strong technical understanding of biologic drug substance and drug product manufacturing, analytical characterization, process development, comparability, and control strategies. The individual will be responsible for driving CMC regulatory submissions, managing Health Authority interactions related to CMC topics, assessing regulatory risks, and supporting successful product approvals and post-approval activities worldwide.

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