Inês Sousa

Regulatory Operations Manager at Astellas Pharma

Inês Sousa is a seasoned professional in regulatory affairs and quality assurance, with a decade of experience at Astellas Pharma from May 2014 to June 2024. As a Regulatory Operations Manager and Responsible Person (Technical Director), Inês ensured the effective implementation and maintenance of quality management systems (QMS), overseeing good distribution practices (GDP) for product distribution activities. Additionally, Inês managed the Regulatory Affairs and Quality Assurance team, facilitating the preparation and submission of marketing authorization applications. Prior experience includes a role as a pharmacist trainee at Farmácia Teixeira Lopes, where responsibilities included order reception and pharmaceutical product storage. Inês holds a master's degree in pharmaceutical sciences from Universidade Fernando Pessoa, earned between January 2005 and January 2010.

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