Fatima Sequeira

Background

About Fatima Sequeira

I am a driven regulatory affairs professional, with a background in synthetic organic chemistry, cellular biology, and a decade of experience evaluating CMC for the FDA (Module 3). My primary focus has been assessing DMF for small molecules throughout their lifecycle to support ANDA and NDA applications. I have also pursued other opportunities resulting in exposure to a diverse range of CMC issues. As I grew in the role, I was entrusted with CMC reviews of Investigational New Drug Applications (INDs) and biopharmaceutics assessment. I acted as subject matter expert (SME) for drug substance, issuing responses to controlled correspondence and assessing post-approval changes for Abbreviated New Drug Applications (ANDAs). My time-management skills along with my sense of teamwork has allowed me to improve outcomes of my own work product as well as my fellow co-workers. I aided my division through drafting SOPs, presentations, and acting as a mentor to junior colleagues. I also took on several technical project management roles to support our division. I hope to bring the same level of technical ability, workflow management, and team spirit to my next role.