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.

• 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.

• Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry,…