Manan Shah

Associate Director, Global Cmc Regulatory Affairs at Takeda

Based in United States

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Seniority

Director

Department

Legal

Location

United States

Industry

Pharmaceutical Manufacturing

Company size

37K

Contact information

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Email

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m•••••••@takeda.com

Phone

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Background

About Manan Shah

Regulatory Affairs leader with 10+ years of experience in CMC strategy and global compliance within the biopharmaceutical industry. Proven track record spanning pandemic vaccine programs to rare disease therapies as Global CMC Regulatory Lead—demonstrating a deep understanding of regulatory complexities across the spectrum from large-scale public health needs to rare diseases. Skilled in global regulatory strategy, FDA import compliance, and cross-functional leadership. Holds an MS in Regulatory Affairs from Johns Hopkins University and RAC-US certification, combining scientific depth with strategic, business-driven insight.

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