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Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle. Collaborate with cross...
Lead global regulatory operations to achieve excellence in compliance and quality across all global projects, staying ahead with up-to-date knowledge on FDA, GCP, and ICH...
Preparing and managing marketing authorization applications; Ensuring product labels, leaflets, and summaries are compliant with regulations; Overseeing product packaging to meet...
Lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial...
Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies;...