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Michele Yelmene has an extensive background in regulatory affairs and quality systems within the pharmaceutical industry. With a focus on global regulatory strategy and efficient approvals, Michele has held various leadership positions in reputable companies such as Xeris Pharmaceuticals, ADVENTRX Pharmaceuticals, and Genzyme. As a Principal at Product Development and Registration Consulting, Michele specializes in regulatory planning, project management, and clinical operations for start-up organizations. With a strong educational background in Biology and English, Michele continues to drive innovation and regulatory compliance in their current role as Vice President Global Regulatory Affairs & Operations at Xeris Pharmaceuticals, Inc.