Area of Expertise:
Heather provides regulatory, CMC, and technical support to the pharmaceutical industry. She is experienced in the preparation, management, writing, reviewing, and publishing of electronic submissions to FDA. In addition, she has assisted in the generation of regulatory strategies for products in the U.S. and the European Union. She also has experience reviewing and developing Quality Systems and performing Quality Assurance (QA) functions such as coordinating or performing quality or complaint investigations, batch record review, and manufacturing change control management and performing compliance audits. Additionally, Heather is experienced in creating and updating Structured Product Labeling (SPL) documents for submission to FDA. Heather has a B.S. in Chemical Engineering with a concentration in Biomedical Engineering from Cornell University.