PDCR - Professional Diploma in Clinical Research (2011) from Catalyst clinical Service pvt.
Extra-Curricular activity Karate: Black Belt in 2005 (Shotokan, Japan Karate association of India) National Champion in JKAI in Goa on 2009,2008,2005,2003 and 2002.
State Champion in JKAI and AIKF in Jharkhand 2003 and 2000.
Participated in 34th National Games 2011, Jharkhand India.
Professional with four (4) years of combined Regulatory Affair operations & Information Technology expertise in using, delivering & supporting large scale, global projects & solutions; incorporating a range of Regulatory Information Management (RIMS) using 'Register' (5.2.x, 5.3.X, 5.4.X, 5.5) - eRIMS (Electronic Regulatory Information Management System), RSM (Regulatory Submission Module), XEVMPD submission, Regulatory Procedure & Documentation, Document Management System (DMS) - (Sharepoint, Firstdoc) & Technologies, & Business process optimization for Life science organizations. Well experienced in Aris Global Register - Regulatory Information Management (eRIMS), its functionalities & usage. Good experience in Data Optimization and quickly understand the business (Regulatory) issues and data challenges of client's organization and respond. Good understanding on EU regulatory procedures like MRP, DCP, CP & National submissions. Responsible for creation & Maintenance of Product Registration of EMA Countries & ROW. Supporting Marketing companies while making various regulatory strategies. Responsible for Electronic Submission of records (Registrations, Renewal, and Variation) to EMA database and get an acknowledgement in the form of EV code. Responsible for ensuring documents to be submitted to health authorities (HA) are appropriately reviewed before exporting the records. Tracking of all the submitted records and received acknowledgements. Verification of Submitted and received Acknowledgements in agXchange RSM. Tracking of all Head quarter level and Local Affiliate level changes (Labeling changes, manufacturing changes) in the Register application. Change Handling process (Variation Process) of all products. Profound knowledge in Pharmaceutical & Medical Device Regulatory submission Process, Dossier Authoring & Publishing, Regulatory Operations, Regulatory affairs IT tools. Well versed with ICH guidelines, 21 CFR Part 11, FDA guidelines, EMA Guidelines, NDA, IND, ANDA, CE Marks, UDI Guidelines, GAMP, GXP & Drug development lifecycle. Prepare requirements specifications and business processes document. Good experience in writing SOP, Work Instruction, Training Guide, workflow document based on Regulatory Business Scenario. Determines the effects of changes in business process on existing applications. Acts as expert functional resource to development staff in all phase development and implementation process. Review of functionality of business systems to ensure that it continues to satisfy users varying needs. Review of document like TCD, STCD, UTCD, RTM in different project. Internally provided Training to the new joiners' within the company on the Life Science Domain and Register (eRIMS) Functionality. Well versed with computer system validation- UAT scripts (End User acceptance Test case),OQ (Operational Qualification) and PQ (Performance Qualification) writing & execution. Experienced in Creating/Reviewing Validation documents like Validation Plan, Protocols (OQ, PQ), Incident Report, RTM, Validation Summary Report. GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting. Worked with validation Management tools (HP ALM/Bugzilla) Performing estimations for Validation and data optimization activities Have extensive domain knowledge in regulatory domain of life sciences vertical. Logical problem solving skills and the ability to thoroughly research issues and analyze various types of information Recognized for Visiual power point presentation, communication, collaboration, and problem-solving skills and ability to serve as an advisor and subject matter expert resource to cloud projects. Have benefited employers with proficiency and discipline, with a personal dedication to excellence, and a willingness to go above and beyond to ensure projects success. Strengths & Skills Systematized execution of work with determination and dedication. Ability to work in a constantly changing environment and capable of working on multiple projects and tasks and completing the necessary work to meet time deadlines. Worked with multinational project teams & coordinates activities on multiple projects.
Aris Global Software Pvt. LtdSenior Regulatory Analyst/Business Analyst | Mysore, India | November 2011 - October 2015
Validation and Regulatory compliance - Business Solution Team.
Implemented user acceptance testing with a focus on documenting defects and executing test cases.
Identified process inefficiencies through gap analysis.
Managed testing cycles, including test plan creation, development of scripts and co-ordination of user acceptance testing.
Mapped process activities to desired outcomes to rectify operational inefficiencies.
Recommended operational improvements based on tracking and analysis.
Conducted interviews with key business users to collect information on business processes and user requirements.
Conducted [Number] knowledge sharing sessions per [Time period] to capture “Lessons Learned” and streamline the product improvement process.
Chicago Stamford, India, IL CT | May 2015 - September 2015
The scope of current project is to understand and gather the customer requirement, create the plan and develop training material for Register application functionality and the Hospira business Process.
Skill Set: Register 542 Functional knowledge Develop the PPT for different topics of Hospira business process - Aris Register application for Product Module, Registration Module, Mater Updates, Local Updates, Variation, Commitment, Interaction, Periodic Notification, Tell & Do, Do & Tell Immediately, and Prior Authorization for Device & Non- Device.
Project 2: Qranberry Project Register 5.4.1 (Onsite Project at Copenhagen, Denmark + India.
Visited onsite for the workshop at LEO Pharma Ballerup Denmark (1 Month).
Prepared Summary Detailed Notes and Minutes of Meetings, SOP and Work Instruction document for below mentioned processes conducted during workshop.
Info from RA.
Annual Product Quality Report) DMF (Drug Master File) creation and variation process for external and internal CEP (Certificate of Suitability for established product) creation, variation, renewal, de-registration (Suspension/Withdrawn) process for external and internal DMF-AR (Drug Master File-Annual Report) NDA-AR (New drug application- Annual Report) PSUR (Periodic safety update report) Authority Meeting Computer Skills Project 3: - Register 55 (April 2015) Client: KaVo Kerr Group: LoJack Responsibilities: Skill Set: Register 542 & 55 Functional knowledge Understand the requirement and develop the Integration test case Document for Screen Customization.
Ranbaxy Laboratories Limited
Skill Set: Register 542 Functional knowledge and Implementation knowledge Interact with the customer & senior management team to understand requirement.
Develop the Requirement Document for Alert for Register 5421.
Develop the Requirement Document for Screen Customization for Register 5421.
Upon completion of requirement authorization, provide the walkthrough to the developer and to the team.
Interaction with the customer & senior management team to understand the requirement for IWB.
Execution of IWB.
Project 6: RegiSTAR 542 TCD preparations for Business Processes.
Skill Set: Regulatory Process knowledge to prepare Business Process TCD.
Interact with customer for the business flow and requirement gathering & Prepare Business processes documents.
TCD preparation for various Regulatory Processes.
Vifor/LFB/Glenmark/Alcon/Biogaran Responsibilities: Preparation and Execution of the OQ's for Register and RSM.
Skills Set: Register 542 and agXchange RSM 552 functional knowledge.
Preparation of Configuration Specification and Verification for Register and AgXchange RSM Verification of Setup and Parameters Execution of Configuration Specification and Verification for Validation and Production environments Screen check in the Production Environment.
Interaction with the customer for the requirements.
Performed the subject matter expert role for the project and resolved the issues rose during project.
Provide training to customer with respect to the functionalities & its configuration.
Respond to the functional issues raised by the customer & provide the solution.
Project 8: UAT SCRIPT writing and End To End Testing (Register 5.4.
UAT script writing & execution as per the Regulatory Business requirement.
Involved in End to End (E2E) test scripts execution.
Prepare Business workflow document with respect to application Functionality.
Prepared Configuration Specification and Configuration Verification Document for Register 541 and 542 Involved in User Requirement Doc preparation and updated Risk Analysis and Traceability Matrix document for Register 541 and 542 Involved in PQ execution for different modules of Register 541, 542 and 5422.
OQ and PQ document review of Register 542 & 5422.
Support for UAT execution in analyzing issues.
Skills required for the Project: Regulatory process knowledge, Regulatory data analysis, Register 525, 53 and 54 functionalities.
Knowledge of EVMPD guidelines.
Involved in the Grow Data project for handling the variations.
Access and Analyze GROW Pack.
Peer Review of head quarter & Local affiliate level changes (Labeling Changes & Manufacturing changes) in the Register (eRIMS) application.
Peer review of created draft submission dossier & Draft Variation Dossier in Register.
Records & publish the meeting notes.
Incorporate follow up items to project deliverable tracking.
Ongoing monitoring & issue escalation to work stream lead.
Project 11: Upgrade from Register 4.x to 5.
Review of Unit Test case (UTCD and STCD) for NN Configuration Project at phase 1, 2 and 3.
Review of Requirement Traceability Matrix (RTM) at phase 1, 2 and 3.
Creation of different Data scenarios in the eRIMS in the Development, Testing and the Validation Environment.
Executed Test case in Development and Testing Environment.
Project 12: Register 5.3.4 Review of System Test case (STCD) document for the Hospira Customization Project and Hospira Annual Periodic Query Report (APQR) Project.
Creation of different Data scenarios in Development, Testing & Validation Environment of eRIMS.
UAT execution for Hospira Customization Project in Testing Environment.
Skill Set: Register 533, 54 Functional Knowledge.
Prepared the Training Guide material on Register (eRIMS) functionality & workflow for Data entry User.
Hands on booklet preparation.
Prepared UAT script validation & Production environment.
Involved partially in Implementation work booklet Preparation.
Project 14: Register and agXchange RSM End to End testing.
XEVMPD testing and Verification of XEVMPD blocks.
Skill Set: Register 52 and agXchange RSM functional knowledge.
UAT script Execution of XEVMPD scenarios.
XML generation and verification of the XML Project 15: Qranberry Project EVMPD- Register (eRIMS) (Register 5.2.5 and 5.3.3).
Data compilation, entry and submission of European drug product related information into 'eRIMS' and Registering it to the different European markets using different procedures type as per the registration summary report (eCTD) given by the client under the supervision of regulatory practice lead.
Track and monitor status of the product during various stages of registration such as planning, application, approval, market launch and renewal, including the IND phase and the NDA phase of the product.
Associate documents from Document Management Systems like Documentum and SharePoint.
Apply changes at product & registration before and after the approval of products.
Electronic Submission of EVMPD records to the EMA database and get an acknowledgement in the form of EV code.
Exporting for EV Code is done using Register (eRIMS) & AGxchange RSM Peer review of EVMPD data quality.
Aris Global Software Pvt Ltd
Completed Internship at Aris Global Software Pvt.
Ltd in the Department of Regulatory Affairs (EVMPD team) for a period of 40 Days starting from 30th Nov 2011 to 11th Jan 2012.
During the Internship I was trained in Register (eRIMS) Application, agXchange RSM, DDLC, EV WEB, Handling EVMPD submissions and GAMP5.
BachelorPharmacyThe Milind Institute of Pharmacy | 2011Pharmacy Bangalore, affiliated to Rajiv Gandhi University of Health Science, Karnataka with aggregate of 70%.