Saima Malik

VP, Regulatory Affairs at Synthekine

Saima has served as Synthekine’s Vice President of Regulatory Affairs since October 2022. Saima has 20 years of overall experience in the biotech and pharma industries, including 15 years of experience in the Regulatory Affairs groups of publicly-held biotech companies based in Silicon Valley. With increasing levels of responsibility, Saima has substantial experience in leading regulatory strategy, collaborating with different cross-functional groups and driving interactions and in-person meetings with global regulatory agencies in North America, the EU, and Asia to guide therapeutic targets into the market for the benefit of patients. Prior to joining Synthekine, Saima was the Senior Director of Regulatory Affairs at Vir Biotechnology where she served as the global regulatory lead for Vir’s flagship Hepatitis B and Hepatitis D programs. Prior to Vir, Saima served as a Director of Regulatory Affairs at Gilead Sciences where she helped lead clinical programs in the inflammation, immunology, oncology, and cardiovascular therapeutic areas. Prior to Gilead, Saima was a Senior Regulatory Affairs Associate and a Research Associate at Genentech where she focused on various oncology and inflammation therapeutic programs in Genentech’s portfolio.

Saima holds a B.Sc. and a M.Sc. from the University of Toronto and an M.B.A. from Golden Gate University.

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Timeline

  • VP, Regulatory Affairs

    Current role