Juliana Schwarz da Rocha

Pharmacist with 14 years of regulatory affairs experience working in pharma and as an independent consultant. Extensive experience in global regulatory affairs having managed preparation of submissions to 50+ countries, spanning from US, EU, Asia-Pacific, and Latin America. Mrs. Shcwarz-Rocha has worked for over 10 years with American companies and managed regulatory activities from development to life cycle-management with FDA. Since 2008 Mrs. Schwarz-Rocha has also supported Brazilian Pharmaceutical Associations either by performing trainings relating to regulatory pathways in the US or through applying her global experience in evaluating regulations issued locally. Recently, beyond its consulting work, Mrs. Schwarz-Rocha has been giving in-company trainings related to the implementation of CTD Dossiers to Brazilian Companies, including the largest pharmaceutical companies in Brazil. Proven written communication and presentation skills. Multilingual: Native Portuguese, Fluent English, and Advanced Spanish. Strong computer skills: Office (Word (including CTD templates plug-in functionalities), Excel, Power Point, Office Project, Outlook); Acrobat, and GlobalSubmit-Review. (Source: Lattes Curriculum)