Bhupendra Sharma M. Pharm

WORK HISTORY

EDUCATION

SKILLS

ABOUT BHUPENDRA SHARMA M. PHARM

A highly passionate regulatory professional with experience in regulatory publishing, submissions, Intelligence and compliance. Hands on experience on document formatting, eCTD structure building, publishing and error troubleshooting using various tools for products on a vast range of therapeutic areas. Experienced in leading team and successful management of multiple projects simultaneously. A detail-oriented and organized professional. A responsible mentor and guide for team to set goals and focus on quality deliverables. Excellent written and verbal communication skills.Applications:eCTD-Xpress, ISI publisher, Cune-eCTD, Insight Publisher, KnowledgenNet, ISI Toolbox, Veeva-vault, PDF Utilities, GDMS (Documentum), Lorenz evalidator, Virtx SPL, Liquent RIMS.Submissions: NDA, ANDA, MAA, DMF, IMPD, DSUR, xEVMPDUS (eCTD): Original, Protocol amendments, Information amendments, Labeling amendments, General correspondences, Annual reports, PADER, SPL Drug listing to Dailymed and FDA submissions using ESG.EU-CP & MRP (eCTD): Original, Variations (Type-IA, IB & II), Supplemental Info, AtoQs, PSURs.EU(NeeS): Original submissions, Renewals, Answer to health authority questions, Supplemental info, Corrigendum, Variations (Type-IA, IB & II).Additional Responsibilities:• Actively involved in process improvement initiatives and knowledge sharing sessions on updated regulatory information to the team.• Actively contributed in recruitment process, development of induction training modules and mentoring new joiners.• Supported product development by streamlining the requirements as set by clients or as per any updates through agency.• Handled client for any concerns wrt to application handling or any guidance required with training on eCTD submissions, document management, data mining and IDMP• Customer support & client satisfaction using Agile tool and Customer service software and support ticketing system.