Uma Raut

Company: Vertex Pharmaceuticals

Job title: Product Lifecycle Director

Bio:

Uma Raut brings over 15 years of global regulatory CMC expertise across the full product lifecycle. Currently Product Lifecycle Director at Vertex Pharmaceuticals, she oversees global CMC strategy for advanced therapeutics, including cell and gene therapies. Previously, she led regulatory affairs and analytical development roles at Takeda, Shire, and Eurofins, guiding INDs, BLAs, and post-approval changes. Her deep experience spans regulatory submissions, analytical method development, lifecycle management, and agency engagement.

Seminars:

Panel Discussion: From First Filing to Final Approval: Inside the Regulatory Journey of Cell & Gene Therapies 9:00 am

Key inflection points, setbacks, and accelerators across IND, BLA, and global filings Building productive relationships with regulators across regions – what worked, and what didn’t? Managing internal alignment and external expectations during late-stage development and approvalRead more

day: Conference Day One