With over 7 years of experience in regulatory affairs for the pharmaceutical industry, I am a specialist in regulatory operations, strategy, and compliance for top health authorities, including the FDA, EMA, TGA, GCC, and MHRA. My expertise covers a wide range of regulatory functions, from submission management to optimizing business processes, ensuring that each submission is timely, accurate, and fully compliant.In my current role as a Regulatory Affairs Consultant, I have successfully led a major system transition to Lorenz DocuBridge and DrugTrack, collaborating with stakeholders to define requirements, author functional specifications, and develop SOPs that streamline workflows and enhance regulatory compliance. This transition was a key element in improving process efficiency and submission quality, resulting in a 90% reduction in validation errors and seamless team adoption through global training sessions that I facilitated.I also bring extensive experience in managing a diverse portfolio of submissions (IND, NDA, BLA, MAA) across US and EU regions, consistently achieving a 97% on-time submission rate. My technical skill set includes proficiency with eCTD, NeES, and paper submission formats, as well as expertise in platforms like ESG, EMA Web Trader, and Veeva Vault.Passionate about regulatory excellence and continuous improvement, I am dedicated to ensuring that products meet rigorous standards and reach patients safely and efficiently. My background in both strategic and hands-on roles allows me to bridge regulatory needs with business objectives, driving compliance and innovation at every stage of the product lifecycle.