I work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process, from submission to post-approval. I execute CMC regulatory strategies with internal and external research and development. I collaborate and influence decisions related to regulatory matters. I develop and implement regulatory strategies for new and existing products in compliance with local regulations. I provide regulatory guidance… Show more I work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process, from submission to post-approval. I execute CMC regulatory strategies with internal and external research and development. I collaborate and influence decisions related to regulatory matters. I develop and implement regulatory strategies for new and existing products in compliance with local regulations. I provide regulatory guidance and support to cross-functional teams. I prepare and submit regulatory submissions to health authorities. I monitor and communicate changes in regulatory submissions to ensure compliance. I collaborate with internal and external stakeholders to ensure regulatory compliance throughout the product life cycle. I contribute to the development and maintenance of regulatory policies and procedures. I provide regulatory training and support to colleagues as needed. I lead and manage regulatory activities for biosimilar and small molecule submissions. I identify and implement best practices for Regulatory Affairs processes and improve efficiency and effectiveness. I provide solutions to a variety of moderately scoped and complex problems. Show less

Atuação em edição de dossies regulátorios pós-registro, tais como renovação de registro, atualização de especificações e métodos analíticos, aditamentos, cumprimentos de exigência e histórico mestre do produto. Realização de auditorias em produtos, levantamento de dados e compliance. Avaliação e abertura de controles de mudança pelo setor.

Elaboração de Relatórios de Revisão Periódica do produto, através das análises estatísticas do dados e busca de melhorias nos processos de produção de acordo com os resultados apresentados.