Susan Batcha
Global Regulatory Cmc Liaison at Novartis
Based in Flanders, United States
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Seniority
Staff
Department
Other
Location
Flanders
Industry
Pharmaceutical Manufacturing
Company size
83K
Contact information
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s•••••••@novartis.com
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Background
About Susan Batcha
Regulatory Affairs pharmaceutical professional having a proven track record of dynamic and effective project management and leadership in Chemistry, Manufacturing and Controls regulatory strategy and execution. Management of a diverse product portfolio including monoclonal antibodies, therapeutic proteins, small molecule, and synthetic peptide pharmaceuticals from early stage development through post-approval life cycle management. Experience complemented by strong background in Production, Compliance and Regulatory Affairs in the in-vitro diagnostic industry. Specialties: CMC regulatory strategy, filings and approvals Biologics and drugs Early development through life-cycle management Comparability protocols Sterile parenterals FDA meetings
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