Pallavi Mallesh

A Regulatory Affairs professional in CMC and submission with a demonstrated history of Working 7+ years of Experience in the pharmaceutical industry with the knowledge of ICH and EU guidelines. •Assisted regulatory support with the compilation, publishing and validation of electronic regulatory applications & submission types such as NDA, IND, ANDA, DMF, MAA, variations (IAIN, IA, IB, II and Notifications), EU CTAs, Renewals and Annual Reports. •Managed the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using document management system, to ensure that said documents meet PDF requirements for Submission. •Hands-on experience of working on publishing tools like Lorenz Docubridge, SAP, ESG Gateway and Clinical Trial Information System.