Divya Lekkala

Experience

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  Tech Mahindra

  Feb 2020 - May 2021

  Associate Analyst

  global regulatory affairs - labelling department• Creation of change order and change awareness notification as per the variations raised to manufacturer products in E.U region as part of Global Labelling activities. • Update artworks to all the markets of European Union for all the manufacturer products according to EMA variations using Harmony Tool. • Ensure that all design and readability guidelines are adhered to across the full range of products.

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  Celegence

  Jun 2021 - Aug 2022

  Medical Writer II

  • Author for systematic literature review reports, clinical evaluation plan (CEP) and clinical evaluation reports (CER) for devices in compliance with MEDDEV 2.7/1 Rev.4 and EU MDR for CE making and approval. • Review systematic literature searches on PubMed, Cochrane, Prospero and Embase database. interpretation of clinical trial searches on EU Clinical Trials, US Clinical Trials, Cochrane Trials and WHO ICTRP websites. • Analysis of adverse event reports, recalls, field safety corrective actions and field safety notices on US FDA MAUDE, US FDA TPLC, MHRA, BfArM and Swissmedic databases. Prepared and facilitated 510(k), PMA, IDE submissions, ensuring adherence to regulatory guidelines and documentation requirements for timely product approval and market clearance.• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. Show less

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  Biogen

  Jul 2023 - Dec 2023

  CO-OP, Material Review Operations Partners

  Developed and implemented an automated reference linking capability and library within Veeva Vault, enhancing efficiency in managing advertising, labeling, promotional, scientific statements, and marketing claims.Collaborated with cross-functional teams to gather data and assess complaint communications for regulatory compliance, reportability, and potential impact to patient safety and business operation.

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  Crown Medical Research and Pharmaceutical Sciences College of Canada

  Apr 2024 - now

  Regulatory Affairs Intern - XN Project

  Internship project in collaboration with Northeastern University Experiential Network (XN) and Crown College of Canada.Internship Supervisor: Professor Peivand Pirouzi, Ph.D.Preparation of submission documents to meet Health Canada's validation criteria and CTD submissions, ensuring full compliance with the Canadian and International regulatory standards.Interpretation and application of ICH-M4 guidelines, and Health Canada's regulations, guidance documents, and policies to effectively prepare, compile, and format regulatory documents in accordance with regulatory guidelines. Show less