Pooja Warange

Support regulatory intelligence and monitoring of regulatory data via internal regulatory intelligence database for multiple clients across EU and US market

Preparation of medical writing documents for EU, US and ROW markets fresh and renewal filing Labels SPC,PI,PIL Clinical Expert Reports (Module 2.5) / Nonclinical Expert Reports(Module 2.4) Annual Report for US NDA Preparation of medical documents to support drug product life cycle & 505b2 projects- Therapeutic justifications, medical write-ups Addressing queries form regulatory agencies, experience in working with MHRA, SAHPRA, Singapore health authority

Experience in Regulatory Information Management(RIIMS).Experties with IDMP/XEVMPD data assessment, data mapping and process definition.Experience in product information documents (e.g. SmPC, PIL, packaging).Well versed with tools likes EVWEB, Liquent Insight and internal databases.Experience in Change control , Updating SOPs and Work Instructions.

During my internship I supported the Medical writing team with Preparation of Labelling documents: Summary of Product Characteristics (SmPC) ,Product Information Leaflet ,Prescribing information/Patient information ,Literature review for Module 4.4 and 4.5 . In the course of my internship, I was exposed to clinical trial site inspection.

Drug regulatory affairs

Pharmacology

Pharmacy