Anusha Pantula
Sr Regulatory Operations Associate @Ngm Biopharmaceuticals
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WORK HISTORY
Sr Regulatory Operations Associate @Ngm Biopharmaceuticals
Review, format, publish, compile and QC (data verification) all sections of global regulatory submissions • Lead publisher of 2 immuno-oncology INDs (NGM831, NGM438) • Expertise in publishing and preparing complex submissions for IND, DMF, CSR’s, IMPD, Annual Reports, and major amendments • Supporting regulatory activities in ex-US and emerging markets • Business admin and trainer for Veeva RIM; Trainer for StartingPoint templates • Manage and control all submission dossiers and related documents in accordance with regulatory guidelines • Pushing submissions through ESG Gateway and QC of submission output • Administarte and organize validated EDMS for submission and document storage • Interacting with cross-functional teams, guiding them on content and coordinating to resolve submission issues
EDUCATION
GITAM Deemed University
Bachelor's in technology, Biotechnology
New Jersey Institute of Technology
Master's degree, Biopharmaceutical engineering
ABOUT ANUSHA PANTULA
Experienced Regulatory Compliance Specialist with a demonstrated history of working in…
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