• Serve as a strategic partner with the Tech Ops and CMC leadership to define regulatory strategies. • Bring hands-on experience to author regulatory submissions within US and Ex-US, coaching and guiding AD/QC staff to author reg submissions. • Work with Tech ops senior leadership to define, develop and execute CGO’s post commercial pathway. • Build sustainable and appropriate organization structure to support CGO future growth from late stage company to a commercial and growing company. • Define and execute the global analytical development strategy across all stages of development, from late-stage clinical through commercial lifecycle management. • Ensure analytical methods are scientifically sound, phase-appropriate, robust, and aligned with regulatory expectations. • Oversee method development, qualification, validation, transfer, and lifecycle management for drug substance and drug product. • Lead and scale Quality Control operations, including in-house and external QC testing activities. • Ensure QC systems meet GMP requirements and remain inspection-ready. • Support regulatory submissions and serve as an analytical SME for health authority interactions. • Build, lead, and mentor a high-performing Analytical Development and Quality Control organization. • Manage external laboratories, CROs, CDMOs, and testing partners. • Collaborate cross-functionally to support tech transfer and commercialization readiness.