VENKATA PRATHAP REDDY RACHAMALLA

Experienced Regulatory affairs professional with overall 3 years of experience in end-to-end Regulatory submission processes which includes but not limited to: Document level publishing activities like Formatting the word documents, Bookmarking, Hyperlinking & creating TOC using tools like ISI-Toolbox, Adobe Acrobat Pro. Submission level publishing i.e., compiling the dossiers in CTD format using different tools like Liquent Insight, e-CTDXpress, Docubridge, Pharmaready, GDMS, Documentum, Lorenz eValidator etc., Vast experience in submitting IND, NDA, Variations and other applications in eCTD/NeeS/paper to different health authorities like US FDA, EMA, Health Canada, AFME, EME, LATAM etc., Experience in creating guidance documents such as Vault RIM Guide, verification guide to assist stakeholders i.e., affiliates & product group Lead process improvement activities like creating interactive dashboards to summarize and evaluate the workload & preparing launch status tracker to give the team an overview of upcoming launches using macros in Excel, Power BI etc. Experience in submission, publishing activities on EU, US-Annual Report and USAdpromo submissions. Very good understanding of guidelines like ICH, GCP, CDISC (SDTM, ADaM) etc.