Ujwala Salke

Experience

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  Freyr Solutions

  Aug 2015 - Sept 2018

  Senior Associate

  -Actively working in various activities which include creation and maintenance of global submission process documentation, standards and strategies that will further enhance dossier preparation capabilities- Keeping the track of the evolving HA requirements and update the DRA team to enhance compliance and process efficiency. - Preparing and publishing of new application and life cycle submission in eCTD and NeeS format- Preparation and submission of CRF and CSR. - Handling submission publishing for INDs, NDAs, BLAs, MAAs, CTAs and IMPDs applications.- Original submissions and life cycle maintenance of dossiers. - Organization and preparation of metadata forms, submission request forms and tracking tools for e-submissions- Follow-up with global colleagues for collection of documents and other submissions related data to ensure the timely submissions to health authorities.- Submissions Handled (IND, NDA, BLA, MAA, DMF, CTA & IMPD): US (eCTD): Original, Protocol amendments, Information amendments, Labeling amendments, General correspondences & INDs safety submissions (7-days, 15-days Initial & 15-days Follow-up), Annual reports, DSURs and CSR publishing.EU-CP & MRP (eCTD): Original, Baseline, Variations (Type-IA, IB & II), Supplemental Info, FUMs, AtoQs, PSURs, RMPs, Articles, Notifications & their dispatches via ESG gateway.Swiss-medic (eCTD) - Baseline, Variations & AtoQsGCC - OMAN, Saudi & Bahrain (eCTD): Baseline, Renewals, Variations and AtoQsEU, GCC & MoW (NeeS) - National & MRPs: Original submissions, Renewals, Answer to health authority questions, Supplemental info, Corrigendum, Variations (Type-IA, IB & II).EU & MoW (Paper format) : CTA / IMPD original, CTA / IMPD amendments and AtoQs, End of trial notification, CSR synopsis .- Hands-on experience in handling of various publishing tools such as ISI (publisher, toolbox and eCTDXpress), Liquent Insight Publisher etc. Show less

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  Teva Pharmaceuticals

  Sept 2018 - now

  • Senior Regulatoy Publisher Associate - III

    Feb 2023 - now

  • Senior Regulatory Submission Publisher - II

    Jan 2021 - Feb 2023

  • Regulatory Associate - Submission Publisher I

    Sept 2018 - Jan 2021