Regulatory Affairs Manager

Department: Regulatory Affairs (Formulation) Location: Kandivali - West, Mumbai Role: Responsible for regulatory activity related to clinical section for US, EU, WHO, Canada, Australia, New Zealand and South Africa Markets Key Responsibilities: Preparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelines Ensure timely preparation of amendments related to bioequivalence to expedite approvals Review of BE protocol for all market including ROW market Review of bio-waiver information and clinical strategy before start of clinical study. Confirmation of reference product for EU countries for clinical study Review and Preparation of 2.4 (non-clinical review) and 2.5 (clinical review) module for EU submissions Review of SmPC, PIL, Labeling for US, EU and other markets with reference product to keep the generic product labeling up to date. Key Activities: Review of technical documents (clinical) on receipt from various Departments before inclusion in dossiers. Discuss and coordinate with cross-functional teams for finalization of documents Preparation and review of clinical section of product dossiers for ANDA filing. Preparing response of queries for USFDA & UK related to clinical section to facilitate product approval. Attend meetings with QPPV for SmPC and PIL related changes. Key Competencies: Qualification Essential : B. Pharm/M. Pharm/Ph D. Desirable : M.Pharma in Pharmacology/Ph D Experience Essential :10 years and above Desirable : 12 years and above Show more Show less