Executive Director CMC Regulatory at AstraZeneca. Remarkable experience (23 years) in pharmaceutical/biopharmaceutical industry in product development, quality, manufacturing, analytical, matrix team leadership, and CMC regulatory. Particular expertise in product development and regulatory strategy for biologics, cell and gene therapy products for US and EU markets, mainly for rare diseases. Strategic and business oriented with solid scientific background and a reputation for building, leading, and retaining high-performing teams. Supported and contributed to over 50 companies in achieving product development milestones by providing product development and regulatory strategy, working with cross-functional teams and leading interactions with Health Authorities (FDA, EMA, and National Competent Authorities). Extensive CMC knowledge in biopharmaceuticals, cell and gene therapy products. Author of 10 peer reviewed articles, and organizer of scientific symposia.