An Assistant Manager of business analysis with 8+ years of experience in Product and project management, actively pursuing a path that marries strategic leadership, business analytics, and a profound commitment to making a positive impact on both organizations and communities. SKills : Expertise in Performing: ● Faclilating and conducting Requirment Discussions/Interviews with Relevant Stakeholders. ● Gathering Requirements & Defining BRD/FRD/PRD from High level Requirements. ● Managing Requirments in Azure devops by creating appropriate EPIC - Feature - User story. ● Estimating and proritzing requirements using various methods. ● Performing Requirment Analysis, Modeling , Impact assessments of the collected Requirements. >Domain expertise : Global Regulatory Affairs (May2020-till date): Durg Product and Medical device, Active ingredients, Composition, packaging, Initial marketing authorizations and handling variations, RIM, Veeva RIM, Veeva Vault,Labelling Management Reports and dashboards, Sequence and Dossier Management ,XEVMPD and IDMP submissions ,SPOR and EMA gateway >Banking and Finance (Oct 2019 – May 2020): IdentityAccess management,Personal Banking >FDA audit ,CSV, Pharma &Lifescience (Jun 2016 – Oct 2019): 21 CFR Part 11,Gamp5 ,Computer system Validations (CSV) ,ALCOA >Projects : Implementation of Veeva RIM in Sandoz(Novartis) Veeva, RIMS, Business analyst, training specialist, Marketing authrozations and its Management. Implementation of SPAR and its Migrations: Handled the intial implementation of the product in Otsuka , Himalaya and its migrations Regulatory affrairs, RIMS , IDMP, xEVMPD, 21CFR part 11, Initial MA and Lifecycle management like variations, CPP, Reports and Dashboards, Notifications and Milestones Was involved in data migrations and carried out resolving project impediments with project manager Handshaking of HRMS system with Identify access management : IAM (identify access management) ,Worked on Application Integrations through API(XML/JSON) and DB.Worked on Web API testings With Postman for both SOAP and REST APIs ,Handling Application Portfolios and Project management. Implementation in charge of TRIMS,DMS,LIMS : Project implementation / Delivery of products such as TRIMS, DMS, and LIMS system to more than 10 clients (including 5 overseas client interactions) - Alkem,Hetero,Adcock,Mankind Etc. GAMP5, 21CFR part 11, CSV, ALCOA ,Client Interaction, Project management ,IQ, OQ and UAT preparation and faclication.Build installations and go live executions