Aicha Otmani

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Pfizer
Director of Regulatory Affairs, CMC
Aicha Otmani is a Director of regulatory affairs, CMC at Pfizer, Inc., where she is responsible for leading global regulatory CMC activities for early phase first-in-human drug candidates through commercialization and life cycle changes. Aicha serves as the regulatory lead for multiple commercial products and manages postapproval changes to ensure compliance, timely implementation, and supply continuity. Additional responsibilities include identifying and characterizing technical and regulatory risks and providing mitigation strategy options during development and registration. Aicha holds a Bachelor of Science in industrial chemistry from the University of Mostaganem, Algeria, and a master’s degree and a PhD in process engineering from Institut National Polytechnique, Toulouse, France.

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CMC Requirements for New Drug Registration in Latin America

The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. This article offers an overview of the chemistry, manufacturing, and controls...