As a Regulatory Affairs professional, I have led regulatory strategy and submission activities for multiple drug development programs across various therapeutic areas, including oncology, hematology, neurology, and rare and orphan diseases. With 25+ years of experience in the pharmaceutical and consulting industry, I have extensive knowledge and expertise in global regulatory affairs throughout all phases of drug development, from pre-clinical to post-marketing.I am a highly-organized, motivated, energetic, and driven individual who excels at communication, interpersonal and negotiation skills. I work effectively with cross-functional teams, internal and external stakeholders, and global health authorities to achieve corporate goals and ensure timely and quality regulatory submissions. I also leverage my consulting experience to provide strategic and operational guidance to clients on regulatory matters, project management, and best practices. My mission is to facilitate the development and approval of innovative and safe therapies that can improve the lives of patients worldwide.