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 Associate Director, 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 Associate Director 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.

Responsibilities:

CMC Regulatory Strategy, Submissions & Dossier Development Develop and execute global CMC regulatory strategies supporting clinical development, registration, commercialization, and lifecycle management of biologic products. Serve as CMC Regulatory lead on cross-functional program teams, partnering with Technical Operations, Manufacturing, Quality, Development, and Supply Chain to align CMC activities with regulatory objectives and timelines. Assess regulatory risks, develop mitigation strategies, and provide strategic guidance for global development programs, including expedited and rare disease programs. Lead preparation, review, and submission of CMC content for global filings, including INDs, IMPDs/CTAs, BLAs/NDAs, MAAs, amendments, supplements, variations, and annual reports. Author and review Module 2 and Module 3 content, ensuring consistency, quality, and compliance with global regulatory requirements. Lead CMC Health Authority interactions and support major registration milestones, inspection readiness, and global expansion activities. Develop regulatory strategies for post-approval CMC changes and lifecycle management, including manufacturing and analytical changes, site transfers, validation, and comparability assessments. Independently lead complex CMC regulatory activities and build effective relationships with internal and external stakeholders. Technical Leadership for Biologics Development Provide strategic regulatory guidance for development and commercialization of biologics, including monoclonal antibodies, recombinant and fusion proteins, and other complex modalities. Advise on regulatory considerations for cell line and process development, scale-up, validation, commercial manufacturing, formulation, fill-finish, and technology transfers. Assess regulatory impact and comparability requirements for manufacturing changes, site transfers, process improvements, and lifecycle activities. Provide regulatory oversight of analytical characterization and control strategies, including critical quality attributes (CQAs), process parameters, specifications, and product characterization.

Education/Experience Requirements:

Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required. Equivalent combination of education and applicable job experience may be considered Advanced degree (MS, PhD, PharmD, or equivalent) in related discipline preferred. 8+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry, including significant CMC Regulatory Affairs experience. Strong technical expertise in biologics drug development programs from development through commercialization, including global post-approval changes, comparability assessments, and lifecycle management required.

Additional Skills/Experience:

The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork Driven, intelligent, passionate about making a difference for patients with rare diseases Demonstrated ability to develop and execute global CMC regulatory strategies. Experience... For full info follow application link. 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