Manish Singireddy
Senior Specialist Regulatory Affairs at Fresenius Kabi
Based in Chicago, United States
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Seniority
Staff
Department
Science
Location
Chicago
Industry
Pharmaceutical Manufacturing
Company size
24K
Contact information
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m•••••••@fresenius-kabi.com
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Background
About Manish Singireddy
RA Professional with an experience of RA and QC/QA • Collaborative knowledge of eCTD publishing, IND, NDA, ANDA, IND-NDA-ANDA annual reports, NDA/ BLA cover sheet, eCTD filing and authoring submissions • Gained knowledge in Prior Approval Supplements (PAS), Changes Being Effected (CBE), collecting product complaints, adverse event reporting, Pharmacovigilance, Site-transfers and CMC sections, change controls • Profound knowledge of regulations pertaining to OPDP • Efficient in interpreting regulatory standards: ICH guidelines, CAPA, GLP, GCP, GMP, ISO 13485, 14971 • Development and review of informed consent, CERs, TMFs, CRFs, protocol, study monitoring plan, data management plan, safety management plan, clinical study reports, SOPs, ICF, IRB submissions • Well aware of regulatory standards of European Union Compliance and EMA for market approval of products • Acquired knowledge of EU Medical devices directives, Confirmatory Assessment Procedures, CE marking • MS Office, Adobe Reader, Adobe Acrobat, FirstDoc (EDMS), ISI Toolbox, ISI Writer, eCTD express, Pharmaready
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