As a seasoned Regulatory Change Manager (RCM) at Pfizer with a strong foundation in the Pfizer tools such as GDMS, Liquent, Lorenz, Rosetta, ISI toolbox and quite few others. A core aspect of my expertise lies in Proficient in document readiness assessments, compiled CMC submission packages, life cycle management, executed QC for final submissions, delivering regulatory dossiers to agencies and adeptly managed regulatory processes for NDA, ANDA, Prior Approval, Post Approval, Queries, and Annual Reports. I bring extensive experience in project management, adept presentation skills, and a proven ability to train and onboard new colleagues effectively. My proficiency in time management ensures the timely delivery of high-quality CMC/Non-CMC Packages, aligned with regulatory guidelines and internal compliance.