Active member of Submission Publishing team, contributing in Publishing (IND, NDA, BLA submissions via ESG - WebTrader ) and life cycle management activities. Training and mentoring new joiners. Reviewing and maintaining integrity of Docubridge Publishing tool. Contributing in publishing New Submissions, Renewals, Variations, Deficiency Letters. Expertise in SAP, DLP, SLP. Continuous written and verbal communication with stakeholders (manufacturing unit, labelling , Business development team )

Working for Sandoz client.Active associate of RegOps team mainly publishing and validating new-submissions, renewals, variations and DL responses using Docubridge. Contributing global market!! Continuous written and verbal communication with stakeholders (manufacturing unit, labelling , Business development team ) Expertise in SAP, DLP, SLP

Expertise in Preparation and compilation of New submissions, renewals and variations. Publishing using eCTD office software and validation via Lorenz eValidator for EU and GCC market. CTD/ACTD dossier compilation/review for Emerging markets. Also have expertise in CMC part review and compilation.Continuous written and verbal communication with stakeholders (manufacturing unit, supply chain, RnD, CQA, Business development team

Expertise in preparation, review & compilation of CTD-ACTD New submissions - Renewals - Variations & Deficiency Letter of Asian region. Drafting and handling Major and Minor change control. Expertise in reviewing GMP, CPP, Labelling and mockups. Continuous written and verbal communication with stakeholders (manufacturing unit, supply chain, RnD, CQA, Business development team)

Pharmaceutical Chemistry. CSIR LS qualified