Assistant Manager

• Jan 2021 - Present

Sr Regulatory Affairs Associate

• Jan 2019 - Jan 2021

Regulatory Affairs Associate

• Feb 2017 - Jan 2019

FDA - Generic Drug Submissions ANDA and Amendments- IR, CRL, control correspondences, Supplements - CBE, PAS, Annual Reports.Assisting QA Team - Change Control Management -RA Change impact assessment and Quality Agreements.

Experimental Network(XN)Project

• Jul 2016 - Aug 2016

Summary- Facilitated the client Genoverde Biosciences Inc., with the regulatory documentation that is required to develop GE organisms in compliance with USDA APHIS BRS regulations, this helps in attaining the non-regulated status of the organisms,that required for introducing it to the United States environment without any further APHIS regulatory oversight. Responsibilities- * Monitored the regulatory documentation of the newly genetically modified pine trees by Genoverde Biosciences Inc. * Followed up with USDA APHIS BRS representatives, to get updated information about the current regulations pertaining to genetically modified organisms (GMO) - Nonfood crops that are useful in developing Pine trees in compliance with the regulations. * Drafted a letter to BRS requesting the non-regulated status to the genetically modified organisms to provides the access for its introduction into United States environment as a non-regulated article. * Summarized the rules and regulations that include state-specific regulations as a guidance document, that helps in importation, the interstate movement of the transgenic plants in compliance with the USDA APHIS BRS rules and regulations. Show less

Senior Process Associate

• May 2013 - Apr 2015

*Parameterised my work activity by supporting and working for a Healthcare project as well as involved in quality control of the process ensuring a quality output as per requirements of clients. *Monitored the case installation process of a firm and its associated Bill Accounts and updating them with its respective premiums. *Facilitated the client by monitoring the Discrepancy's in the Billing Accounts and ensured that discrepancies are identified and corrected by regenerating them from the respective effective date of the billing account. *Performed the Risk mitigation activity through the Root cause analysis technique. *Took initiatives as Floor supporter to ensure the associates are processing the work as per the process requirements and compliance. *Ensured the quality and accuracy parameters of the client and achieved it by performing the role as an Auditor. *Conducted weekly training sessions for twenty to thirty internal staff members to provide the team with the current process knowledge and updates. *Organized the schedule for bi-weekly internal team meetings and issue meeting minutes. *Performed weekly dashboards review by Consolidating the process data, and Updating the reports to the clients. Show less

Process Associate

• Oct 2011 - May 2013

* Responsible for providing technical solutions based on part set up and maintenance and facilitating the requestors to place their respective sales orders by troubleshooting complex issues. * Ensured that parts are updated with Inventory carrying values in the market maker application by doing respective follow up with the costing team. * Facilitated the end Customers-Hospitals by maintaining sourcing rules for the part numbers to the respective Inventory organization so that parts can be shipped from Manufacturing organizations to distribution organizations and finally to hospitals. * Responsible for Conducting periodic reviews with the client’s and analyzing their trends to ensure that requested tasks are completed with accuracy and within stipulated TAT. * Authoritative for the maintenance of parts set-up in oracle GLPROD tool for Deployment organizations like DDK(Denmark), DSE(Sweden), DES(Spain), DNL(Netherlands), DLT(Turkey) and DNO(Norway). * Responsible for resolving the IT issues of the team members by taking up an initiative as an IT catalyst. * Facilitated the requestors to place their respective sales order by updating the prices for the parts in the requested Price lists. * Responsible for Meeting management, setting up meetings, maintaining minutes, action and decision log. * Facilitated the team members by providing cross-training with the process knowledge. Show less