Regulatory Affairs Team Lead
CurrentActive 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 )