Melanie Sorensen

Lead Regulatory Strategist
Cytiva

Melanie Sorensen is a Lead Regulatory Strategist for Cytiva, and globally recognized Fortune 50 equipment and life sciences technology company. As a senior regulatory affairs leader, and a patient herself with deep connection to the oncology and cell and gene therapy communities, she has the ability to connect regulators, technology innovators, and patient voices in way that enables drug developers and service providers. Each year Melanie and her team leads more than 100 certification and registration submissions across FDA CBER/CDER, USDA, PMDA, EMA, EU Competent Authorities and other global health authorities. She is also a pioneering member of Cytiva Regulatory Science leadership team, which is focusing on enabling best-in-class regulatory support to Cytiva customers.

Presentation(s):

• Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) Designation and Global Perspectives

  Wednesday, September 18, 2024
  2:15 PM – 3:15 PM PDT