Aarti Sharma

Background

About Aarti Sharma

Experienced Senior Global Program Regulatory Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Regulatory Affairs, Regulatory Requirements, Regulatory Submissions. Strong legal professional with M.Pharmacy and MS focused in Pharmaceutical Chemistry from Jaipur National University and Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy and Health Science, Boston respectively. I am responsible for publishing, verification, management and dispatch of regulatory dossiers to health agencies worldwide. Do publishing and validation of regulatory submissions in NeeS, eCTD and Paper format using state-of-the-art software applications. Expert in handling publishing tools such as ISI Publisher, eCTDXpress, TRS, ISI toolbox and Adobe Acrobat Standard and validation tools like Extedo and Lorenz validator. Hands on experience in handling submissions such as IND (Investigational New Drug Applications), NDA (New Drug Application), sNDA (supplemental New Drug Application), sBLA (supplemental Biological Drug Application), Labelling supplements, DSUR (Development Safety Update Report), Annual Reports, EU and US Briefing Books, EU and US Orphan Drug Applications, Clinical Trial Application, MAA (Marketing Authorization Applications), Variations (Type IA, IAIN, IB, II, Grouping, Work-sharing), EU Referrals, PSUR (Periodic Safety Update Report), RMPs (Risk-Management Plans), PIP (Paediatric Investigational Plans), Follow-Up Measure, CDS documents and MRP eCTD (Mutual recognition Procedures eCTD) submissionsProvides strategic and operational expertise to teams on regulatory and technical aspects of submissions to ensure timely and efficient handling of submissions. My expertise also includes electronic submission in US & EU and NeeS submission in Most of the World.