Chetan Khade

Background

About Chetan Khade

Currently working As Assistant Manager in Regulatory Affair (Complex Generic Product (Injectables Peptides and oligonucleotides )- Central Dossier Team with Cipla market handles: US, EU, UK, Austrialia, south Africa,Australia, suadi Arabia, Mexico, Brazil, Columbia.Role :1. Compilation.review and submission of high quality Dossier To US FDA as per the guidance. Reviewing of documents as per RTR point of view for legibility and for completeness as per MAPP guidances2.Compilation and submission of high-quality US /Europe/Brazil dossiers,Mexico, Columbia, Australia, UK, respecting agreed CMC regulatory strategy, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirementsDificiency response, Scientific advice compilation.3.Identify the required documentation for submissions and negotiate the delivery of documents in accordance with project timelines.4. Collecting data from various CFT departments and outside vendors for preparation of dossiers to support the product registration.5. Review and approval of various CMC documents.6. Evaluation, compilation, review and submission of deficiency responses during registration and ensuring timely submission of deficiency response. Preperation of scientific advice documents for Europe UK,SA,AU markets8. Having knowledge about the Dossier requirements for various countries, international and ROW. PDF processing of submission documents as per eCTD requirement. 10.Evaluate the change with respect to quality and planning of strategy for submission of post approval suppliments (eg. CBE 30,PAS)