Uma Raut
Director GRA-CMC, Cell and Gene Therapy at Vertex
- Role
- Associate Director Regulatory Affairs at Takeda
- Location
- Woburn, MA, US
- LinkedIn followers
- 500 followers
About Uma Raut
Extensive experience in analytical development and protein characterization working in close collaboration with cell culture and purification process development, manufacturing operations, and quality control. Analytical coordination for projects from early clinical development to commercialization.
Experience
Associate Director Regulatory Affairs
Dec 2019 — Present · US
Responsible and accountable for regulatory CMC development, registration and post-approval strategies. Ensure that global strategies are successfully executed across both new product development and existing portfolio life cycle management.• Lead team members that define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with the established requirements. • Represent Takeda RA CMC in Health Authority meetings and leads preparation activities for meetings with Health Authorities on CMC related matters • Evaluate change proposals for global regulatory impact and plans global variations and amendments.
Education
University of Rhode Island
MS, Biomedical Sciences, General
1997 — 1999
Government of Maharashtra
BS, Biomedical Sciences; Pharmaceutics
1993 — 1997
University Of Bombay
BS, Pharmaceutical Sciences
1993 — 1997
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