Senior Manager, CMC Regulatory Affairs (Biologics)

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.

Responsibilities

• 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.

• Audit 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.

• 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.

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 Phase 3 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/Requirements

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• 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.