Nikhitha Johnson

Background

About Nikhitha Johnson

Regulatory Submission Management Expert With more than 5 years of diverse and hands-on experience in the dynamic field of Regulatory Affairs, I have honed my expertise in end-to-end submission management across a global landscape, including the US, Canada, EU, Switzerland, Australia, Thailand, Taiwan, Bahrain, and GCC countries. Expertise in Regulatory Submission Publishing: I excel in managing complex regulatory submissions, ensuring meticulous preparation, timely execution, and full compliance with regional and international regulatory requirements. My proficiency spans handling IND, ANDA, NDA, BLA, MAA, NDSs, SNDSs, CTAs, NCs, Clarifax, NON, NOD, Nees, and DMF in CTD/eCTD formats. Regulatory Project Management: I am adept at leading regulatory projects, orchestrating cross-functional team collaboration, and liaising with clients to achieve submission targets within stringent timelines. My project management skills are complemented by a strong foundation in lifecycle management of regulatory dossiers. Technical Skills and Tools-Adobe Plug-ins: ISI Toolbox, IRPT -eCTD Software: Rim Smart, Veeva Vault, Lorenz validator -Office Suite Proficiency: Microsoft Word, Excel, PowerPoint, Adobe Acrobat PRO DC, Outlook