Nadejda Soukhareva
About Nadejda Soukhareva
Nadejda Soukhareva serves as the Executive Director of Regulatory Affairs at Insmed Incorporated, where she directs global regulatory strategy and oversees regulatory operations. She has held various roles in regulatory sciences across multiple organizations, including Leadiant Biosciences and Sigma-Tau Pharmaceuticals, and has a background in Biology from Samara State University.
Current Role at Insmed
Nadejda Soukhareva serves as the Executive Director of Regulatory Affairs (Global Regulatory Strategy) at Insmed Incorporated. She has held this position since 2021, overseeing the development and implementation of global regulatory strategies. Her responsibilities include directing regulatory scientific strategy, chemistry, manufacturing, and controls (CMC), regulatory operations, and labeling and promotional labeling activities. Soukhareva provides counsel and management to the regulatory team, ensuring the successful submission and approval of international marketing applications.
Previous Experience in Regulatory Affairs
Prior to her current role, Nadejda Soukhareva held several significant positions in regulatory affairs. She worked at Leadiant Biosciences, Inc. as Senior Director of Regulatory Sciences from 2018 to 2020. Before that, she was the Director of Regulatory Sciences at Sigma-Tau Pharmaceuticals, Inc. from 2010 to 2018. Her earlier experience includes roles at Aeras Global TB Vaccine Foundation as a Senior Regulatory Affairs Associate and at Emergent BioSolutions as Manager of Regulatory Affairs. Each position contributed to her extensive expertise in regulatory processes.
Educational Background
Nadejda Soukhareva studied at Samara State University in Russia, where she earned a Master of Science degree in Biology/Biological Sciences. Her educational background has provided her with a strong foundation in the biological sciences, which supports her work in regulatory affairs and strategy.
Career Timeline
Nadejda Soukhareva's career spans several years in the field of regulatory affairs. She began her career as a Research Specialist at the American Red Cross from 1998 to 2005. She then transitioned to roles in regulatory affairs, including Analyst IV at Immune Tolerance Network from 2004 to 2006, and Senior Regulatory Affairs Associate at Aeras Global TB Vaccine Foundation from 2007 to 2009. Her career progressed with significant roles at Emergent BioSolutions, Sigma-Tau Pharmaceuticals, and Leadiant Biosciences before joining Insmed in 2021.