Manan Shah

Manan Shah is the senior manager for regulatory affairs at G&L Healthcare Advisors and is a regulatory affairs consultant with over 10 years of experience in the biopharmaceutical industry.

He has a deep understanding of regulatory frameworks, guiding companies through complex CMC, FDA import, and submission processes. His excels in crafting and executing regulatory strategies for biologics and pharmaceuticals and leads interdisciplinary teams to develop effective regulatory approaches. Recently, he played a key role in supporting client strategies for COVID-19 vaccine market entry and distribution.

Shah has contributed to a diverse array of initiatives, including NDAs, supplemental filings, and post-approval processes. Proficient in FDA and EMA regulatory landscapes, he ensures clients meet all standards and directives. Before his regulatory career, he obtained an MS in Biotechnology, focusing on Regulatory Affairs from Johns Hopkins University, and holds an MSc in Genetic Manipulation and Molecular Cell Biology from the University of Sussex.