Strongly reliable and focused Regulatory Affairs consultant with expertise in RIMS. Superb multitasker able to handle multiple projects efficiently and accurately. Effective independent worker as well as excellent coordinator with other members of a regulatory affairs team.Regulatory Submission management for the Clinical Trail application (CTA), an overview of EU, Swiss, UK Dossier Publishing and dossier Handling Submission level publishing involved in EU procedures like National, Centralised, Decentralised and MRP procedure. Various submissions like Single, Worksharing, Grouping submissions, PSUSA, Non-PSUSA submissions, CMC core Package submission,MA Transfer and Site Name Change submissions.Dispatching of submissions to respectiveHA's via CESP, ESG and MHRA portals.Experience in handling of various Submission publishing tools like eCTDXpress, Liquent Insight Publisher, eCTD office, Insight for viewer (14V), Doc Bridge, RIMS like Veeva Vault Submission creation, archiving and dispatching.Experience in handling of various validation tools like Extedo validator, Lorenz validator Document publishing tools like ISI tool box, Liquent Smartdesk and Adobe acrobat DC.As a part of work, training new resources is an additional privilege and recognition for the same.