A dedicated and passionate regulatory affairs personnel with more than 3 years of experience in healthcare and cosmetic arena. Excellent understanding of regulatory submissions and extensive experience in providing support to regulatory team.o Extensive experience in providing excellent support to regulatory manager – preparing, assembling and submitting quality documents for cosmeceutical products in EU market and ANDA (generic) products to USFDA. o Experience in preparing eCTD submission: - Worked on Module1 and Module 3.o Possess strong adaptability to change - ability to switch to new projects quickly. Assisted manager with quality testing and always willing to help with other projects.o Proven ability to meet deadlines with time management skills – proven record of finishing all the projects within deadline.o Excellent organisational and multitasking skills- handling multiple projects at the same time.o Strong communication skills as well as proficient writing skills with good computer literacy – preparing responses and liasing with EU consultant. Worked on eCTD express software, ISI writer and ISI toolbox.o Operating systems: Windows XP/7/8. Proficient in Microsoft Outlook, Office- Word, Adobe reader, Power Point, Excel, SPSS,SAP,AccPac and Access. o Detailed knowledge of TGA regulations for: Cat 1, Cat2, and Cat 3 submissions for prescription and OTC medicines. CMI, PI and GMP certifications. NeeS submissions.