Estagiário, Assuntos Regulatórios (Sao Paulo, Brazil) job opportunity at BeOne Medicines.

Home Jobs In Brazil Tag: Assuntos Regulatórios (Sao Paulo, Brazil) Estagiário, Assuntos Regulatórios (Sao Paulo, Brazil) position at BeOne Medicines


DateMore Than 30 Days Ago bot
BeOne Medicines Estagiário, Assuntos Regulatórios (Sao Paulo, Brazil)
Experience: General
Pattern: full-time
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Assuntos Regulatórios (Sao Paulo, Brazil)

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degreeGeneral
loacation São Paulo, Brazil
loacation São Paulo....Brazil

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Education Required: Graduação em andamento no curso de Farmácia e Bioquímica, com vínculo estudantil ativo durante todo o estágio. General Description/Scope of Responsibilities (Internship): Assuntos Regulatórios garante a conformidade dos produtos, desde o registro e pós-registro até o ciclo de vida (rótulo/bula, variações e renovações), atuando junto à ANVISA e demais órgãos competentes. Como estagiário(a), a posição dará suporte direto às rotinas da área, adquirindo conhecimento, desenvolvendo visão crítica, organização e comunicação técnica. Essential Functions of the Internship: Preparar, organizar e revisar documentação técnica para submissões de registro e pós‑registro (variações, renovações, atualizações de rótulo/bula), seguindo guias e normas vigentes. Elaborar submissões no formato CTD (Commom Technical Document) em formato eletrônico conforme sistemas de informações regulatórias da empresa. Auxiliar no peticionamento eletrônico e no acompanhamento de processos junto à ANVISA (ex.: montagem de dossiês, protocolos, taxas/GRU, controle de prazos e status). Apoiar respostas a exigências técnicas (compilação de evidências, versionamento de arquivos, controle de prazos e envio). Manter bases de dados e indicadores (trackers, planilhas e sistemas internos) atualizados, garantindo rastreabilidade e integridade de dados. Dar suporte na revisão regulatória de bulas e rotulagens (checagem de dizeres, layouts e atendimento a legislação). Contribuir na gestão de licenças e certificações (ex.: AFE, CBPF) e interface com Vigilâncias Sanitárias locais quando necessário. Apoiar processos regulatórios relacionados à importação e liberação de produtos, em parceria com Qualidade e Importação. Acompanhar mudanças regulatórias (monitoramento de publicações oficiais de regulamentações) e elaborar sumários de impacto para o negócio. Participar da atualização de POPs/SOPs e treinamentos internos da área. Organizar arquivos e gestão documental (versionamento, nomenclatura, trilhas de auditoria). Acompanhar e monitorar produtos da concorrência, bem como apoiar a Inteligência Regulatória desenvolvida na área. Computer Skills: Microsoft Office Outlook Sharepoint Teams Adobe Acrobat Other Qualifications: Organização, planejamento, proatividade, atenção a detalhes e comunicação escrita e oral claras. Inglês intermediário ou avançado. Travel:   0% of time Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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