Pooja Warange

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