ABOUT US

AMY LEVIN

VP REGULATORY

  • Ms. Levin has a successful track record of leading and collaborating with cross-functional teams and regulatory authorities to author, manage and review required reports of the U.S. Food and Drug Administration (FDA) and international regulatory submissions.

  • Previously, she worked as Director, Roche Molecular Diagnostics (RMD) International Regulatory Affairs at RMD after serving in many roles with increasing leadership responsibilities within the company.

  • While there, Ms. Levin drove the development and implementation of regulatory strategies for introducing new products in the marketplace and negotiated with worldwide health authorities to enable expeditious approval and importation of products across more than 50 countries.

  • She has also held other regulatory positions at multiple Biotechnology companies in the San Francisco Bay area.

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