Haribaabu Aamudaalapallii
Manager Global Regulatory Affairs @Amgen
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WORK HISTORY
Manager Global Regulatory Affairs @Amgen
Telangana, IN
EDUCATION
University of Saskatchewan
Master of Science - MS, Chemistry (Enzymology)
Osmania University
Bachelor of Science - BS, Biotechnology, Chemistry and Botany
Jawaharlal Nehru Technological University
Master of Science - MS, Biotechnology
ABOUT HARIBAABU AAMUDAALAPALLII
Seasoned regulatory affairs professional with 15+ years of multidisciplinary experience spanning regulatory CMCsubmissions, biosimilar development and Academics. Demonstrated success in leading regulatory filings to globalmarkets (EU, UK, and Canada) and subsequent approvals. Skilled in quality change management, change controlassessments, and quality data review. Strong foundation in analytical development, technology transfer, methodvalidations, physicochemical characterization, and conducting stability programs for biological drug products, and committed to continuous learning and regulatory excellence to drive innovation and market success.
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