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Regulatory Affairs Officer

A combinar Período Integral Efetivo – CLT. Home Office
São Paulo - SP
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Descrição

  1. Área e especialização profissional: Saúde - Análise Clínica
  2. Nível hierárquico: Analista
  3. Local de trabalho: São Paulo, SP
  4. Technical Skills/Experience
  5. Degree in life science-related discipline or professional equivalent
  6. Regulatory lifecycle maintenance experience, focusing on marketed products
  7. Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/aggregate reports) Experience in new MAA applications in Europe and/or emerging markets an advantage
  8. Good understanding of pharmacovigilance activities relevant to marketed products
  9. Preferably has experience in managing regulatory projects
  10. Interaction with Regulatory Agencies (EU/EMA)
  11. Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets
  12. Preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts
  13. Experience in quality review of technical/ regulatory documents
  14. Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate
  15. HOME- BASED
  16. Soft Skills
  17. Excellent verbal and written communication skills in English are essential
  18. Well organised
  19. Be able to manage peaks of workload and prioritise workload with some supervision
  20. Ability to work to tight timelines
  21. Open and communicative personality
  22. Good team player
  23. Good negotiating skills
  24. Ability to identify issues and contribute to their resolution
  25. Strong computer skills, including MS Office applications, data and document management systems
  26. Adaptable to change
  27. Cultural awareness

Exigências

  1. Escolaridade Mínima: Ensino Superior
  2. Português (Nativo), Inglês (Avançado)

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  • Jornada Período Integral
  • Tipo de contrato Efetivo – CLT
  • Salário A combinar
  • Localidade São Paulo, SP
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