Urvi Shah

Urvi Shah is an experienced professional in regulatory affairs with a strong background in the pharmaceutical industry. Currently serving as Manager of Regulatory Affairs CMC at Biogen since February 2022, Urvi specializes in regulatory strategy and marketing authorization applications (MAAs). Prior experience includes a role as Principal Associate in Regulatory Affairs at Seqirus, focusing on vaccines and regulatory strategy, and a position as Regulatory Affairs II at Sandoz, dealing with regulatory strategy and new drug applications (NDA). Earlier work as a Regulatory Affairs Specialist at Halozyme Therapeutics involved clinical data management and NDA submissions. Urvi began a career as a Senior Pharmacy Technician at Express Scripts, where responsibilities included enhancing dispensing practice guidelines and ensuring compliance with state laws. Educational qualifications include a Master's degree in Pharmacy Administration and Pharmacy Policy and Regulatory Affairs from The University of Georgia and a Bachelor's degree in Pharmaceutical Sciences from C.K. Pithawalla Institute of Pharmaceutical Science & Research.