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**Principais Responsabilidades**

Participação efetiva na construção e execução da estratégia de registro e pós registro de medicamentos, em especial os oncológicos, produtos para saúde ou cosméticos, incluindo discussões com as áreas envolvidas (indústria, clínica, médica);
Execução de processos com autonomia, proatividade, assertividade, senso de urgência e organização;
Elaboração de processos de PSUR para submissão a ANVISA, com base nas documentações e informações recebidas da matriz;
Controle e respectiva atualizações da bula dos produtos, assim como a comunicação às áreas impactadas, sempre que houver atualizações das mesmas. Cuidando para que a bula atualizada seja disponibilizada no site da empresa;
Execução do fluxo, junto as áreas envolvidas e sistema da matriz, das artes dos produtos, novas ou atualizações necessárias;
Abertura de Controle de Mudanças no sistema local, sempre que houver alteração recebida através do Regulatórios, assim como dar o apoio com as informações regulatórias necessárias a novos projetos locais ou em sites internacionais, sempre que o produto for suprido ao mercado brasileiro, cuidando para que as regulamentações brasileiras sejam respeitadas;
Monitoramento de regulamentações novas ou atualizações e processos regulatórios relacionados a seus produtos e plantas, em jornais ou outras mídias no Brasil (ex. Diário Oficial da União/site imprensa/ANVISA/outros);
Revisão de materiais promocionais e de treinamento relacionados aos produtos da empresa, de acordo com as regulamentações e códigos de conduta locais, assim como procedimentos internos da empresa;
Elaboração de SOPs (POP) local, alinhados aos da matriz e de acordo com as regulamentações locais;
Participação em reuniões para palestras ou reuniões técnicas nas associações, como SINFAR, SINDUSFARMA e INTERFARMA, assim como na ANVISA;
Fazer coaching, conforme orientação da diretora do departamento, de um dos colegas do setor durante um determinado período, o acompanhando em seus processos e ajudando em seu desenvolvimento profissional.

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.