As an independent Regulatory Affairs and Innovation Consultant based in Cincinnati, Ohio, I specialize in providing strategic regulatory support to clients in the pharmaceutical, biotech, and medical device industries. My role involves developing regulatory strategies, writing and editing regulatory documents, and assisting clients in FDA interactions to ensure compliance and successful product approvals. Additionally, I manage projects and build action plans to optimize development programs and timelines.Previously, I served as Senior Director of Regulatory Affairs and Medical Writing at Medpace, a mid-sized clinical contract research organization (CRO). In that role, I built and led a team of regulatory medical writers and CMC experts responsible for drafting regulatory documents for drug, biologic, and medical device submissions worldwide. I also contributed as a subject matter expert in medical devices and engineering. Earlier in my career, I worked at Pfizer, where I designed and developed medical devices. As the project lead for new device initiatives, I oversaw R&D teams and managed the entire innovation project lifecycle, from concept to global launch. I prioritized the development portfolio, created product strategies, scaled products for production, expanded market reach globally, managed vendor relationships, and handled forecasting and budgeting, all while applying structured innovation processes. I enjoy combining my expertise in science, research, business, and collaboration to solve complex problems and deliver value.Areas of Expertise: - Regulatory Affairs, regulatory medical writing, strategy, project management, and planning - Bringing new medical therapeutics and technologies to market - Defining and addressing challenging problems with an eye for improvement and efficiency - Collecting and analyzing data to solve problems and capitalize on opportunities - Collaborating with leaders to influence organizational strategy and drive growth - Translating complex information into practical, business-oriented solutions - Enhancing business processes for optimal efficiency and impact - Making data-driven decisions - Building high-performing teams