Fatiha Qadao UI Laüer

Fatiha Qadao UI Laüer

Regulatory Affairs Team Leader Innovation Area @ Laboratoire Aguettant

About Fatiha Qadao UI Laüer

Fatiha Qadao UI Laüer is a Regulatory Affairs Team Leader in the Innovation Area at Laboratoire Aguettant, where she has worked since 2021. She has over 11 years of experience in CMC regulatory expertise and project management in the pharmaceutical and veterinary sectors.

Work at Laboratoire Aguettant

Fatiha Qadao UI Laüer serves as the Regulatory Affairs Team Leader in the Innovation Area at Laboratoire Aguettant. She has held this position since 2021 in Lyon, Auvergne-Rhône-Alpes, France. In her role, she proposes mitigation plans to de-risk Chemistry, Manufacturing, and Controls (CMC) strategic decisions through early communication with worldwide health authorities. She leads the preparation of CMC sections of regulatory dossiers and responses to Ethics Committees and Health Authorities, ensuring compliance with regulatory standards.

Education and Expertise

Fatiha Qadao UI Laüer has a robust educational background in chemistry and quality management. She obtained a Two-year University Degree in Technology, specializing in Chemistry, from IUT Paul Cézanne Aix Marseille III from 2006 to 2008. She further pursued advanced studies, achieving a Second-year Master’s Degree in Chemistry and Quality from Université Côte d'Azur in 2011, and a First-year Master’s Degree in Quality Management from Aix-Marseille University in 2010. Additionally, she earned a Licence in Molecular Chemistry from Aix-Marseille University in 2009.

Background

Fatiha Qadao UI Laüer has over 11 years of experience in CMC regulatory expertise and project management across both veterinary and pharmaceutical sectors. Prior to her current role, she worked at Ipsen as CMC Regulatory Strategy Manager from 2012 to 2020, where she communicated key regulatory CMC guidance to Pharmaceutical Development teams and stakeholders. She also held positions at Virbac as Post-MA Coordinator & Study Manager and at ProductLife Group as CMC Team Lead, where she developed and supervised CMC regulatory strategy roadmaps for multiple projects.

Achievements

Throughout her career, Fatiha Qadao UI Laüer has demonstrated significant leadership in regulatory affairs. She has been responsible for coaching and developing junior resources within the CMC Regulatory Strategy group. Her work involves leading the preparation of CMC sections of regulatory dossiers, which is critical for compliance with health authority requirements. Her extensive experience in the field has positioned her as a knowledgeable resource in CMC regulatory strategy.

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