Regulatory Affairs professional with over 7 years of comprehensive experience in global regulatory submissions, CMC documentation, and product lifecycle management for Pharmaceuticals and Biologics. Expertise in preparing INDs, IMPDs, NDAs, BLAs, and ANDAs, with a strong command of ICH guidelines and eCTD submissions. Proven ability to lead cross-functional teams, manage post-approval changes, and ensure compliance with health authority requirements across diverse markets. Skilled in leveraging advanced regulatory tools such as Veeva Vault QMS, RIMS, TrackWise, Pharma Ready Application and Lorenz e-validator to streamline processes, accelerate approvals, and support global regulatory strategies. Driven by a commitment to regulatory excellence and continuous improvement.I specialize in evaluating CMC changes, developing effective strategies for selecting the appropriate regulatory filing categories, and identifying the necessary supporting documentation for post-market supplements, including PAS, CBE-0, CBE-30, and annual reportable changes.With a deep understanding of 510(k) submissions, Premarket Approvals (PMAs), PMA supplements, and Investigational Device Exemptions (IDEs), I bring extensive expertise in navigating complex regulatory pathways for medical devices.Additionally, I have a strong grasp of regulatory frameworks such as US FDA and EMEA regulations, along with comprehensive knowledge of international standards like ICH, GCP, GMP, Quality Standards, and Quality Management Systems.