Roles & Responsibility:Dossier preparation/ review per country specific guideline/ CTD guidelines.Timely query response, submission to Distributor / MOH.Review of documents for their correctness and compliance with respective regulatory guidelines (as per country requirement).Preparation, review and release of artwork and sales order as per country approval.Variation documents preparation and filling as per country requirements.Timely dispatch of tender documents to country/ parties as per deadline. Preferred candidate profile : Regulatory Affairs experience is mandatoryShould be able to review and interpret the country specific requirements.Should be able to review various plant documents for dossier preparation like process validation, Stability Study, PDR, Method Validation, SOP, Drug Master file, BMR, APR, etc. Should be able to communicate with relevant counterpart in the countries.