Harsha Adoni is a Regulatory Affairs Associate at Roche since April 2025, responsible for managing safety-related submissions and Chemistry and Manufacturing (CMC) submissions, along with leading pre-submission meetings with Health Canada and maintaining compliance within regulatory systems. Prior experience includes serving as a Senior Associate in Regulatory Affairs Labelling at Fresenius Kabi Canada (October 2023 - April 2025) and positions at Health Canada, where duties involved pharmacovigilance, drafting regulatory responses, and managing inquiries related to health products. Harsha holds a Graduate Certificate in Regulatory Affairs from Seneca College and a BDS in Dentistry from Manipal College of Dental Sciences.
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