Daniela Winograd serves as a Senior Manager in Regulatory Affairs Advertising and Promotion at Astellas Pharma US, where she leverages over 18 years of extensive experience in the pharmaceutical industry. Her deep expertise encompasses a wide array of regulatory frameworks, including those established by the...
Daniela Winograd serves as a Senior Manager in Regulatory Affairs Advertising and Promotion at Astellas Pharma US, where she leverages over 18 years of extensive experience in the pharmaceutical industry. Her deep expertise encompasses a wide array of regulatory frameworks, including those established by the U.S. Food and Drug Administration (FDA) and various international health authorities such as EMEA, ANVISA, and COFEPRIS. In her current role, Daniela is instrumental in ensuring that all promotional materials and advertising strategies comply with regulatory requirements, thereby safeguarding both the integrity of Astellas’ products and the health of consumers.
Daniela's key projects often involve navigating complex regulatory submissions and overseeing the development of Standard Operating Procedures (SOPs) that streamline compliance processes. Her proficiency in drug and device regulations, coupled with her experience in Good Manufacturing Practices (GMP), positions her as a vital resource within the organization. She is adept at conducting thorough reviews of labeling and promotional content, ensuring that all communications are not only compliant but also effectively convey the intended message to healthcare professionals and patients alike.
Fluent in multiple languages, including Portuguese, Spanish, Russian, and French, Daniela enhances Astellas' global outreach by facilitating clear communication across diverse markets. Her ability to engage with international stakeholders and understand local regulatory nuances allows her to lead initiatives that align with both corporate objectives and regional compliance demands. As a thought leader in regulatory affairs, Daniela Winograd continues to drive innovation and excellence in advertising and promotion strategies at Astellas Pharma, contributing to the company’s mission of improving health outcomes worldwide.
