- Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch - Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines - Oversee critical development activities including process development, scale-up, manufacturing validation, analytical method development, and packaging/labeling evaluation - Manage cross-functional collaboration as a Subject Matter Expert and Technical Lead, partnering with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure seamless program execution - Champion quality and compliance by implementing Quality by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and commercial success - Build and mentor high-performing teams while managing budgets and timelines to deliver robust, scalable, and cost-effective pharmaceutical solutions