Anusha Pantula
- Role
- Sr Regulatory Operations Associate at Ngm Biopharmaceuticals
- Location
- Mountain View, CA, US
- LinkedIn followers
- 500 followers
About Anusha Pantula
Experienced Regulatory Compliance Specialist with a demonstrated history of working in…
Experience
Sr Regulatory Operations Associate
Jan 2021 — Present
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
2010 — 2014
New Jersey Institute of Technology
Master's degree, Biopharmaceutical engineering
2015 — 2017
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