Anshu Kumari

Freelance publishers @ Pharmalancers Ltd

About

• Hands on experience with Veeva Vault RIM suite including Registrations, Submission Content Planning, Authoring, Review, Approval, eCTD binder compilation, and HA Communications • Good knowledge on the formats and versions specified in the FDA Specifications for file format types using eCTD Specifications. • Maintained specifications as per company SOP’s, GMP’s and formats for various departments. • Experience in Submission planning activities like creation of events, activities, regulatory objectives, and submission records according to defined classification and naming conventions • Experience in creation of submission content plans using defined templates and as per requirement of specific countries • In-depth knowledge of Veeva Vault platform, System Administration/Configuration for RIM, and QDocs. • Experience in coordination for pharmaceutical product registrations and submissions (including publishing and archiving), and tracking of health authority communications • Good understanding of GxP, ICH, 21 CFR Part 11, EU Annex 11, and CSV regulations applicable across the globe in context of regulatory applications

Country

United States

City

Novi

Industry

Pharmaceuticals

Skill

Good Manufacturing Practice (GMP), Pharmacovigilance, Good Clinical Laboratory Practice (GCLP), GCLP, Good Laboratory Practice (GLP), Regulatory Requirements, Publishing Management, Document Management, Electronic Submissions, Good Clinical Practice (GCP), eCTD xpress, Extedo eCTD manager, Mikado, Insight suite for publishing, Global validator, NeeS, eCTD express, In sight tool, Lorenz, Regulatory Affairs