Srikanth A

Experience

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  First Indian Corporation Private Limited

  Jan 2006 - Nov 2006

  Data Processing Executive

  Providing Technical Support to Mortgage Tools.Verification and Quality check for US mortgage properties documents.

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  BA Continuum Solutions Private Limited

  Dec 2006 - Aug 2010

  Team Developer

  •Provided technical support for the Banking related Citrix applications like Ruby, Sapphire.•Worked as a System Administrator for the Citrix applications.•Managed a team size of 40 members as an assistant team leader.

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  Novartis

  Sept 2010 - Mar 2013

  Technical Regulatory Operations - Business Administrator II

  Manage the activities of the Business Administrators for systems used by DRA, e.g. REDI, eCTDXPress,ISIPublisher, CoreDossier and DRASA.Collaborate with respective DRA Ops groups in BS, the US and Japan for global strategy and planning.Maintain a current knowledge of Health Authority requirements for electronic submissions in order to recommend changes to IT systems and business processes.Collaborate and coordinate with other line functions plans for upgrades of applications or IT environment. Show less

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  Wipro technologies

  Apr 2013 - Jul 2014

  Technical Consultant

  •Providing L2 and L1 technical support for the end-users by troubleshooting the issues from server level.•Preparing & modifying the SOPs, Working Instructions & Business guidance documents as per the requirements from the client/customer.•Verifying the server logs and sending to the Vendor and getting updates from the Vendor.•Executing the IQ scripts in Production, Validation and Development environments.•Managing the User accounts and security role maintenance through Insight Manager.•Installation of Hotfix releases in Production/Development/Validation environments.•Tracking issues reported to the Global Help Desk, working with the user groups to prioritize these issues.•Working with the vendor to resolve the issues and implement system upgrades and installing software, if necessary.•Monitoring and informing the status of the Terminal / Remote Server performance to the end-users and the Vendor.•Monitoring the submissions proactively from the end user and troubleshooting the issues immediately and verifying the job status.•Verifying the Active / Network directory, if the user is unable to access the application. •Monitoring the server performance and related log files.•Preparing and reviewing the Troubleshooting document and managing the checklists.•Working directly with the Vendor for the major issues related to the server through Teleconference / WebEx sessions. Show less

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  Freyr Solutions

  Jul 2014 - Apr 2016

  Regulatory Operations Manager

  Reporting to the Global Head of Regulatory Operations & Compliance, Novartis OTC Division Regulatory Information Management Specialist: Systems & Submissions.Support regulatory submissions to global health authorities through the management of drug product information and regulatory events.Deliver technical and development information to support compliance initiatives.Liaise with internal and external regulatory affairs counterparts to ensure quality of information and effective delivery of data as per FDA,European, Canadian & Asian guidelines.Managing communications with Novartis affiliates to resolve data or information inaccuracy issues. Analyzing regulatory data to promote accuracy of information through regulatory software systems. Updating regulatory information periodically. Maintaining knowledge of Novartis over-the-counter products.Promote quality information through evaluating and compiling of data for submissions.Production of training materials for regulatory process tracking and user interface of Regulatory Information Management Systems & Software.Co-ordinate the updating of regulatory information and systems integration across regulatory software platforms: OTCDocs (Documentum D2),Register (ArisGlobal) and Trackwise (Sparta).Maintain knowledge of eCTD structure & submissions(FDA Certificate) Software: Documentum D2, Register, Trackwise, SAP Business Objects BI. Show less

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  Pfizer

  Apr 2016 - Jan 2019

  Deputy Manager

  •Worked as a Centralized Data Management (CDM) Cluster Lead for APAC & EME Markets for Regulatory Information Management System handling 10 data & senior data associates.•Working closely with Global Process & Compliance teams to streamline the process of Single Channel of Communication.•Monitoring & assigning the workload to the team and working closely with all the markets for Asia Pacific & EME markets getting on boarded into the new SCC process within RIMS.•Started career with Pfizer into publishing domain responsible for monitoring the Publishing workload and assigning the Publishing activities. •Reviewing the dossiers compiled by Publishers •Review and interpret the data provided to establish the RIMS system / tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope•Ensure team receives appropriate training materials and its correct implementation•Adhering to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance•Coordinate the development of guidelines and keeping them updated holding key information on how to perform system update considering each market specifics•Coordinate with remote/local peers to ensure compliance with local and global regulatory requirements. •Develop and propose strategies to improve efficiencies and effectiveness while managing the data management activities. •Adhere to the appropriate use of technical tools, through use of working practices and qc/qa procedures such as regulatory and internal compliance. •Lead cluster data associate team using the performance management framework and development process that provides an overall context and framework to encourage employee contribution; includes goal setting, feedback, and performance development planning Show less

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  Celegence

  Feb 2019 - Oct 2019

  Associate Manager

  •Regulatory Business SME for Novartis Training workstream project•Defining the Training Project plan, project charter, Training strategy, Training Development•Responsible for using and updating RA systems like Regulatory Information Management System (RIMS), Document or Content Management System and eCTD Submissions•Manage various activities under product lifecycle management (Registrations, Variations, Renewal submissions)•Preparation of User manuals, training slides, best practices, process flows, FAQs for RIMS application•Support Implementation of Regulatory Affairs systems as per Client requirements Show less

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  GSK Consumer Healthcare India

  Oct 2019 - now

  Regulatory System and Metrics Analyst

  •Partnership with DevOps group in developing Regulatory Veeva Vault RIMS system up-to date with latest enhancements•Mentoring India Systems Team (Group of 13)•Interacting with Cross functional Business Stake Holders in liase with their Business Processes within RIMS •Providing Regulatory Veeva Vault trainings to Cross Functional SMEs•Support in Writing/Updating the New/Existing Quick Reference Guide(s) for RIMS (Veeva Regulatory Vault)•Creating User Stories in JIRA and participating in the below key discussions: Product Increment Planning Workshop Daily Meetings Backlog Refinement Sessions Sprint Planning Sprint Review Retrospective Discussions Show less

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  Haleon

  Jul 2022 - now

  Regulatory Systems and Metrics Analyst

  •Identify and drive system or process changes to enhance data quality, user experience and compliance•Communicating the vision of the product to the stakeholders and the development team•Defining the features of the product according to customer requirements with well-defined User Stories and Acceptance Criteria for each feature •Participating in Scrum events and collaborating with the development team by Organizing and ranking the items in the product backlog according to requirements•Support in Writing/Updating the New/Existing Quick Reference Guide(s) for RIMS (Veeva Regulatory Vault)•Helping the scrum/product development team achieve each sprint’s goals•Evaluating feedback and measuring the value of the product by Informing stakeholders and customers about the product’s status Show less