Lucas Moretti Email and Phone Number

• Coordination of Global Projects in Vaccines for Latam Region• Support the Global team with inputs for strategy for the submission and approval of variations concerning Latin America products• Support and definition of post registration registration strategies for products belonging to Latin American countries• Assessment of proposed variations for vaccines and carrying out impact analysis in the region• Management of communications with local and global teams to ensure synergy of strategies• Support for transversal teams and participation in discussions related to the continuity of business in the countries of the region

• Coordination of Global Projects for Industrial Affairs• Regulatory and Technical compliance assessment for Cosmetics, Food Supplements and Medical Devices• Evaluation of technical requisites and formulas under the perspective of in-forced regulations and the quality standard of the company• Support with communications to External Manufacturing clients• Regulatory Support for New Projects interfacing with External Manufacturing, Global Regulatory Department and Local Affiliates

- Ensure delivery of regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers- Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements.- Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.- Review tasks for, support and mentor Regulatory Affairs Officers and Associates.

▪ Review of technical documents (CMC sections of the CTD, validation reports, bioavailability studies, non-clinical and clinical studies) according to current norms.▪ Regulatory feasibility analysis for new registrations in different categories, such as Rx, OTC, Phytotherapic Products, Biological Products, Food Supplements, Medical Devices and Cosmetics.▪ Active participation in face-to-face meetings with the Health Authority to discuss submission strategies and queries.▪ Review and elaboration of regulatory strategies for pipeline products including budget and submission plan▪ Review of promotional material with strategic eye

▪ Management of regulatory projects regarding complex variations or NDA submissions.▪ Legislation analysis and market tendencies.▪ Preparation and review of NDA dossiers for new molecules and generic drugs.▪ Preparation of Variation dossiers for new molecules, biological products and generic drugs.▪ Labelling review and approval.▪ Management of strategic reports.▪ Promotional material review.▪ Regulatory support for importation processes.▪ Regulatory feasibility analysis for new business development.

▪ Support in the preparation of NDA dossiers.▪ Preparation of variation dossiers for new molecules, biological products and generic drugs.▪ Promotional material review.▪ Regulatory support for importation processes.▪ Regulatory feasibility analysis for new business development.

Montagem de processos, avaliação de variações e interpretação de legislação sanitária. Aprendizado no processo de petições da ANVISA, interpretação e aplicação de legislação sanitária e análise estratégica envolvendo o setor regulatório.

Foi desenvolvido um projeto sobre as interações gênicas da proteína de matriz do vírus sincicial respiratório. Envolvendo conhecimentos avançados de biologia molecular e técnicas laboratoriais.