Regulatory Affairs Executive

Description: Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC, and other legal documents including product permission Preparation of registration documents as per ACTD , CTD , country format / Review / Preparation & Compilation Preparation of text matter and checking of artworks. Should coordinate with the factory for samples, working standards, document data, license related documents. Should have knowledge with regard to checking samples. Courier of documents and samples to the respective customer. Maintaining status and record of dossiers, and samples legal documents.