Fatima Sequeira

Background

About Fatima Sequeira

I bring over 11 years of experience in CMC evaluation at the U.S. Food and Drug Administration (FDA), assessing regulatory strategies across the full product lifecycle—from pre-submission through post-approval. I have successfully led both technical and cross-functional teams, driving improvements in cohesion and efficiency, resulting in better work product. My foundation in regulatory strategy is built on deep expertise in reviewing Module 3 of Drug Master Files (DMFs) and regulatory submissions, including INDs, NDAs, and ANDAs. What I bring from the FDA is my knowledge of different CMC strategies and ability to reason and justify CMC approaches. In 2024 alone, I assessed over 80 Module 3 submissions across a diverse range of companies, therapeutic areas, and regulatory approaches. As a subject matter expert (SME) in drug substance, I provided authoritative guidance on CMC strategies through industry-facing communications, such as control correspondences, and critically evaluated the impact and justification of post-approval changes. Recognized for being self-motivated, resourceful, and insightful, I leverage both regulatory and scientific expertise in synthetic organic chemistry and cell biology to develop and communicate robust CMC strategies that align with global regulatory expectations and support product success.