Vaga de parceiro

Regulatory Operations Manager - São Paulo / SP

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Detalhes da Vaga

  • Escolaridade Não Informado
  • Segmento Não Informado
  • Salário Não Informado
  • Área de AtuaçãoDiversos / Outros

O que você irá fazer

  • This role involves supporting the regulatory affairs teams, particularly in the US and Latin America, by ensuring the accuracy and efficiency of regulatory operations.
  • The ideal candidate will have a strong scientific background, preferably in pharmacy, medicine, chemistry, or biology, and experience with regulatory systems like Veeva RIM.
  • Particular focus on content planning and publishing are core competencies for this role.
  • The position requires at least three days per week in our Sao Paulo Brazil office to foster collaboration and team integration.
  • This is an excellent opportunity for someone looking to grow within a diverse, vibrant, and supportive team environment at P&G.
  • As the Regulatory Operations Manager, you will: Collaborate with cross-functional US PHC team members, building team members understanding of documentation requirements for compliant eCTD-submissions.
  • Work with Regulatory Affairs and submission team members to define metadata necessary to update Veeva RIM records.
  • Work with Regulatory Affairs and submission team members to define dossier content for submissions in the United States.
  • Content planning Management: Manage the process from creation to submission of dossiers to the FDA while ensuring document alignment, document status monitoring and enabling publishing.
  • Drive the troubleshooting of systems (e.
  • g.
  • , Veeva RIM, Content planning & publishing etc) and applications based on their technical proficiency.
  • Provide document management support, as needed, to facilitate on-time delivery of electronic submission ready documents.
  • Champion data verification and enable data literacy among users.
  • Drive/lead process improvement, dossier management and data governance in both LATAM and North America.
  • Understand the business processes and the needs of the end user and design packaged systems with proper impact analysis, custom programs, front-end applications, and integrations that adhere to best practices and meet user needs.
  • Contribute to data-driven decision making by leading/driving the interpretation and analysis of data from various sources (reporting capabilities).
  • Job Qualifications Education: Degree in Life Science (Pharmacy, Medicine, Chemistry, Biology) or previous regulatory/regulatory operations experience.
  • Minimum 3 to 5 years experience in Regulatory Affairs or Regulatory Operations.
  • Extensive experience in a highly regulated scientific environment, interacting with and interpreting various laws and regulations globally (Human Safety/R&D/Quality) preferably in the United States & Canada.
  • Having Latin America experience would be a plus.
  • Job Schedule Full time Job Number R000125440 Job Segmentation Experienced Professionals (Job Segmentation) Starting Pay / Salary Range: $85,000.
  • 00 - $115,000.

Informações Adicionais

  • Quantidade de Vagas 1
  • Jornada Não Informado
 

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