Verified recordBiotechnology Research

Gowri Sukumar

Senior Director Cmc and Regulatory Affairs at Iterion Therapeutics

Based in Houston, United States

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Seniority

Director

Department

Research & Development

Location

Houston

Industry

Biotechnology Research

Company size

Contact information

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g•••••••@iteriontherapeutics.com

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Background

About Gowri Sukumar

Dynamic and strategic Regulatory Affairs and CMC executive with 15+ years of experience leading global development programs in oncology, orphan diseases, and advanced therapeutics. Proven track record of guiding regulatory strategies and CMC operations from preclinical through commercialization, with expertise in INDs, NDAs, BLAs, and global health authority engagement (FDA, EMA, Health Canada).Recognized for securing accelerated pathways, directing successful CDMO partnerships, and delivering high-impact regulatory submissions. RAC-certified leader known for cross-functional leadership, innovation in drug development, and thought leadership through patents, publications, and speaking engagements. Passionate about building agile teams and driving regulatory excellence in small biotech environments.

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