Regulatory Affairs job vacancy at Noida in Bhargava Phytolab

Preparation of CTD/ACTD & Country specific Dossiers • Handling queries obtained from different regulatory agencies and customers across world. • Compilation, preparation and review of Technical Package of APIs. • Compliance to audits of regulatory bodies especially USFDA and EU. • Generation of documents from, Production, QC and QA of newly developed products • Responsible for record keeping and to ensure correctness of records pertaining to department. • Knowledge of ICH Guidelines to prepare documents accordingly • Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, Investigator’s Brochure, clinical study reports) Desired Competency