🔹️ Regulatory Affairs: ~7 years of experience- End to end Submission Management: Expertise in handling Regulatory Submission Publishing for US, EU, UK, Health Canada, RoW, GCC market - Life cycle management of dossiers- Hands on experience on:Adobe plug-in: ISI Toolbox and Liquent SmartdeskMS word plug-in: ISIWriter and Starting Point Template (Author)eCTD softwares: eCTDXPRESS, Lorenz docuBridge, Liquent Insight Publisher, eCTDViewer, Lorenz eValidator and dispatches via CESP, ESG or EMA repository. - Well versed with the DLP, SLP techniques, troubleshooting of lorenz errors, dispatches and post submission archival activities.- Handled CMC activities: Technical review of documents, review CCFs, track effective documents from QUMAS, preparation of submission modules for ANDA & compilation of Annual Reports. Document management in Veeva Vault.- Coordination with team members and with CFTs/clients to achieve submissions in timeframe.- Stays updated with Regulatory Guidances, GDUFA goals, Submission RA Strategies & Submission Planning. Always seek learnings.