Kathi Rinesmith

Mrs. Rinesmith serves as Aprecia's Senior Vice President of Regulatory Affairs, where she will lead the company’s regulatory strategy, objectives, policies,and programs pertaining to the company's marketed and pipeline products. Her more than 30 years of experience spans the development and registration of pharmaceutical products from early to late-stage product development, during which she has demonstrated success leading sponsor teams at FDA meetings and through the registration review process with the FDA for new product approvals. In addition, she’s been responsible for product life-cycle management, fulfillment of product post-approval reporting obligations and global pharmacovigilance for commercial products as well as those in development. She has also contributed toward industry initiatives to develop science-based approaches to regulation by serving on a past Product Quality Research Institute (PQRI) Packaging Committee, by serving on a USP Expert Committee for Pharmaceutical Dosage Forms for a 5-year term and by providing industry feedback on draft FDA guidance documents.