Simone Pinto Email and Phone Number
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• 15 years’ experience in regulatory affairs and quality control in sectors such as Cosmetics, Sanitary Products, Consultancies, and Health Regulation.• Highly experienced in managing individuals and multifunctional Regulatory Affairs teams in Brazil, Mexico, and the Latin America region in general. • Skilled in building effective relations with regulatory bodies such as ANVISA, VISA, Business Associations, Civil Police, Federal Police, the Ministry of the Army.• Specialist in drafting defense briefs and monitoring inspections, audits, CONAR (Brazilian Advertising Self-Regulation Council) cases, and judicial investigations.• Experienced leader of risk assessments and crisis management teams.• International experience includes participation in training on new procedures in Germany and Mexico, networking on best practice and liaison with management teams throughout the world - 2015 to 2017.
Arxada
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Gerente De Assuntos Regulatorios LatamArxada Apr 2022 - PresentSalto, São Paulo, Brazil -
Supervisora De Assuntos Regulatórios LatamLonza Do Brasil Especialidades Químicas Ltda. Sep 2020 - Apr 2022Salto, São Paulo, São Paulo• Apoia as metas, objetivos e demandas das unidades de negócios (BUs) na América do Sul. Responsabilidade das atividades direcionadas pela gerência; Garantir o cumprimento das diretrizes regionais e internacionais da empresa; Garantir que as atividades de registro de produto estejam emconformidade com os requisitos de legislação/regulamentação das agências governamentais.•Gerenciar projetos regulatórios das Unidades de Negócio: elaboração de planos de registro (o que, quando, quanto, quem) e estimativa de prazos.• Responsável por contratar laboratórios (deal w / contracts); obter documentação necessária, informações bibliográficas, etc., para cumprir os requisitos de registro.• Gerenciar as submissões de dossiês de registro para órgãos relevantes (ANVISA, MAPA, IBAMA), dentro dos prazos exigidos e realizar acompanhamento contínuo.• Gerenciar as renovações, obtenções ou manutenções de licenças de funcionamento junto aos órgãos competentes, levando em conta os requisitos e prazos estabelecidos.• Coordenar as análises e teste de laboratórios e acompanhamento dos resultados (discussões técnicas dos laboratórios).• Suportar Regulatório Globalmente para informações, alinhamento, notícias relevantes para a área.• Receber inspeções de órgãos públicos e propor ações e manter a conformidade.• Elaborar e revisar os rótulos dos produtos, quanto à conformidade regulatória.• Gerenciar e garantir documentação e FISPQs dos produtos de modo a atender os requisitos locais.• Suportar o negócio para envio de documentação para clientes, relacionados aos produtos, para suporte a registro e outras documentações.• Suportar pedidos de clientes externos (consultas por telefone e email).• Participação em reuniões de associação para discussão e influência da regulação; e dar orientação às BUs.
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Gerente De QualidadeRazzo Ltda. Apr 2020 - Sep 2020São Paulo, São Paulo, BrasilReporte ao CEO e aos Sócios da Companhia.Gerenciamento dos programas e sistemas aplicados aos processos, de forma a se obter aumento da confiabilidade, produtividade, otimização de sistemas e processos e redução de custos operacionais.Gerenciamento, acompanhamento e implantação dos projetos Razzo e dos clientes de terceirização, como NIVEA, NATURA, AVON, UNILEVER, entre outros.Gerenciamento dos processos e procedimentos, elaboração de fluxogramas de documentação das áreas, gerenciamento e execução dos programas de auditoria interna.Gerenciamento das Auditorias de Certificação e de Clientes.Gerenciamento e execução das ações de Assuntos Regulatórios, como Licenças e Registros.Gerenciamento e execução das ações de Governança Coorporativa.Liderança e gerenciamento dos 21 colaboradores sob minha responsabilidade.
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Quality & Regulatory Affairs ManagerBdf Nivea Brasil Jul 2015 - May 2018São Paulo Area, BrazilReported to the Supply Chain Director, leading a team of four. • Reduced the number of product registration applications rejected by ANVISA (Brazilian Health Regulatory Agency) to zero and reduced the number of registration-related issues to almost zero, significantly reducing registration times.• Organized and chaired meetings between the Regulatory, Legal, Marketing and R&D departments of the company’s operations throughout Latin America to discuss and take forward new products. • Reduced the number of fines applied by INMETRO (Brazilian Institute of Metrology, Standardization and Industrial Quality) by 90% by introducing continuous improvement tools and processes. • Carried out the company’s first regulatory risk assessment in Brazil and helped operations in the rest of Latin America complete their assessments.• Worked closely with the Communications, Customer Service and Legal teams to introduce Crisis Management Procedures.• Developed and deployed tools and strategic meetings to review complaints from consumers and clients, reducing such complaints by more than 35%.Implemented a quality management system in the Cosmetics Distributor, improving efficiency.• Set up a quality team focused on distribution, transport, outsourcing, audits, and consumer/client complaint management.Led the quality and regulatory aspects of the Nivea Doll project, intended to educate the public in the use of sunscreen products.Worked closely with the toy manufacturer Estrela on tests of sunscreen products and the Nivea Dolls, changing the sunscreen in the promotional kit to increase the profit margin by 6%, and reduce consumer complaints by 80%, with a matching reduction in the logistics costs involved in product exchange. -
Regulatory Affairs CoordinatorBeiersdorf Apr 2011 - Jun 2015ItatibaReported to the Quality and Regulatory Affairs Manager, with a team of one. • Coordinated and implemented the regulatory process involved in transferring the distribution of Eucerin brand products from Laboratories Ache to Beiersdorf, including changes to the ANVISA registration, revised labeling, producing the Eucerin website, training the Consumer Service team on the products and responses to technical questions.• Planned actions required as the result of newly-enacted laws and communicated the changes to the regulatory and R&D teams to minimize their impact on the company.• Improved the corporate image by representing the company in meetings with ANVISA, VISA, INMETRO and industry associations such as ABIHPEC (Brazilian Personal Hygiene, Perfumery and Cosmetics Industry Association).• Participated in the implementation and consolidation of the cross-functional group which brought together Regulatory Affairs, Legal, Marketing, and Consumer Services to discuss product labeling and communications strategies for product launches and relaunches.• Responsible for the technical training of the customer service team, creating the database of ingredients and their functions and reviewing technical responses to consumer inquiries, improving efficiency and reducing consumer response times to less than 24 hours.• Technical responsibility for the distribution center. -
Senior Analyst - Regulatory AffairsBeiersdorf Sep 2007 - Apr 2011Itatiba• Responsible for the registration and post-registration processes for the Eucerin line of dermocosmetics, establishing an effective relationship with the team at Laboratories Ache and aligning the processes with the international team.• Analyzed continuous improvement tools and processes in order to reduce the number of fines applied by INMETRO.• Reorganized and deployed systems with details of products subject to control by the Federal Police, Civil Police and Ministry of the Army.• Introduced new procedures and management tools to reduce the number of product registration applications rejected by ANVISA to zero and reduce the number of registration-related issues to almost zero, significantly reducing registration times.• Represented the company at meetings with ANVISA, VISA, INMETRO and industry associations such as ABIHPEC, building closer relationships with those bodies. -
Regulatory Affairs AnalystRbr Regulamentação E Registros Feb 2007 - Sep 2007São Paulo• Responsible for the registration, post-registration and notification of sanitary products, cosmetics and pesticides with ANVISA, IBAMA and MAPA (Ministry of Agriculture, Fisheries and Supply).• Analyzed and drafted opinions on reports of the similarity of Pesticides under national and international laws.• Represented companies in technical meetings with ABIQUIM (Brazilian Chemical Industry Association) and MAPA.
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Regulatory Affairs AnalystJbs S/A May 2006 - Nov 2006Luziânia• Responsible for the registration, post-registration and notification of sanitary products and cosmetics with ANVISA • Represented the company in technical meetings with ABIQUIM, ANVISA and VISA.
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Specialist In Health Regulation And OversightNational Agency Of Health Surveilance - Anvisa May 2004 - May 2006Brasília Area, Brazil• Analysis of registration and post-registration processes and notification of sanitary products.• Preparation of reports to management with the main reasons for notifications of requirements and the rejection of applications.• Training to increase the registration of products and companies with ANVISA and combat piracy.
Simone Pinto Skills
Simone Pinto Education Details
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99 From 100 -
Food Technology And Processing -
Química
Frequently Asked Questions about Simone Pinto
What company does Simone Pinto work for?
Simone Pinto works for Arxada
What is Simone Pinto's role at the current company?
Simone Pinto's current role is Regulatory Affair Officer | Public Affairs | Compliance | Quallity | Judicial Investigation.
What is Simone Pinto's email address?
Simone Pinto's email address is si****@****ail.com
What schools did Simone Pinto attend?
Simone Pinto attended Mit Sloan Executive Education, Universidade De Brasília, Universidade De Brasília.
What skills is Simone Pinto known for?
Simone Pinto has skills like Microsoft Office, Desenvolvimento De, Management, Microsoft Excel, Regulatory Affairs, Sap, Negotiation, Desenvolvimento De Produtos, Bens De Grande Consumo, Planejamento Empresarial, Gmp.
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Simone Pinto
Head Hunter | Especialista De Rh | Gente & Gestão / Psicóloga | Consultora De Rh | Treinamento & Desenvolvimento / Recrutamento & Seleção / Endomarketing / Cultura Organizacional / Coaching / Avaliação Por CompetênciaRio De Janeiro, Rj
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