Amy Tezel, PhD
“My focus is helping clients make every conversation they have with a regulator count. This means working with them to set clear objectives and develop messages that resonate with their toughest audiences. The preparation is rigorous, but the reputation of integrity and credibility clients achieve always pays off when challenges arise.”Contact Amy
Amy leverages a powerful combination of scientific, regulatory, and communications expertise to help clients achieve success in their highest stakes regulatory interactions.
Amy focuses on helping clients truly understand what their regulatory audiences need and want to hear so they can anticipate questions and concerns to pre-empt review issues and achieve their objectives. She has demonstrated success with submission strategy and writing, FDA meeting preparation, Advisory Committee and Panel meetings, and developing and executing global regulatory strategies. Amy utilizes her abilities to translate complex scientific and clinical data into clear messages, taking into consideration the broader regulatory landscape.
Amy has more than 15 years of experience in global regulatory affairs and has held regulatory leadership positions at Allergan, Alcon, and BVI Medical, spanning a wide range of therapeutic areas. She specializes in clinical and regulatory strategy – helping companies work with regulators to get products approved for patients in need. Amy received a Bachelors of Science degree in Chemical Engineering from the University of Washington and a PhD in Chemical Engineering from the University of California at Santa Barbara.
Amy enjoys traveling with her husband, reading, running, and hiking, and is an enthusiastic soccer mom for her three young daughters. She also serves on the board of her local arboretum.