Regulatory Affairs Specialist

4 semanas atrás

São Paulo, Brasil Insight Global Tempo inteiro

Job Description:
The position will have primary responsibility in the Global Development Information Management team. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA) and cross-functional stakeholders (e.g., IT, Clinical, Nonclinical, Quality). Identify opportunities within the RIM platform, to enhance compliance, efficiency, and reporting. Responsible for supporting RIM Reporting and Analytics needs across Global Regulatory Affairs as needed.
Responsibility:
Support efforts to align business processes to a RIM enterprise data strategy.
Contribute to implementation of E2E RIM which includes new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting, etc.
Ensure user’s requirements are adequately documented and serve as the basis for system continuous improvement, process engineering/mapping, and/or new system selection.
Conduct training and support change management activities in RIM implementation and upgrades.
Track alignment of business processes and models across all business functions supporting global Regulatory product registrations.
Lead and/or support initiatives to integrate Regulatory information and records globally and for acquired assets and products.
Monitor emerging structured data standards or health agency requirements, assess business impact and define roadmap for addressing them.
Required Skills and Experience:
6+ years of experience in working in a biotechnology or pharmaceutical Regulatory Affairs Operations environment
Experience in systems management or implementation in the life sciences industry or regulated industry.
Must have experience in Veeva Vault RIM
Other system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (PromoMat, eTMF, Quality)
Microsoft Office and Adobe systems
• Knowledge of regulations, processes and industry standards and best practices that govern regulated systems, records retention and GxP

Compensation: $15/hour - $25/hr USD

  • Regulatory Affairs Specialist

    Há 7 dias

    São Paulo, Brasil ICON Plc Tempo inteiro

    Regulatory Affairs Specialist - São Paulo ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Regulatory Affairs...

  • Regulatory Specialist

    Há 3 dias

    São Paulo, Brasil EBANX Tempo inteiro

    Build your future with Sovos. If you\'re seeking a career where innovation meets impact, you\'ve come to the right place. As a global leader, Sovos is transforming tax compliance from a business requirement to a force for growth while revolutionizing how businesses navigate the e... Regulatory Affairs Specialist We are seeking a Regulatory Affairs...

  • Senior Regulatory Affairs Specialist

    2 semanas atrás

    São Paulo, Brasil Monster Energy Tempo inteiro

    OverviewSenior Regulatory Affairs Specialist at Monster Energy. The role focuses on registrations and compliance for raw materials and finished products, and collaboration with regulatory leaders and the regional NPD team to support product registrations and labeling in dynamic markets. The Day In The LifeAs a Sr Specialist in Regulatory Affairs, you will...

  • Senior Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, Brasil Monster Energy Tempo inteiro

    Overview Senior Regulatory Affairs Specialist at Monster Energy. The role focuses on registrations and compliance for raw materials and finished products, and collaboration with regulatory leaders and the regional NPD team to support product registrations and labeling in dynamic markets. The Day In The Life As a Sr Specialist in Regulatory Affairs, you will...

  • Regulatory Affairs Specialist

    3 semanas atrás

    São Paulo, Brasil Smith & Nephew Tempo inteiro

    Regulatory Affairs Specialist (São Paulo) page is loaded## Regulatory Affairs Specialist (São Paulo)locations: Brazil - office positionstime type: Full timeposted on: Posted Todayjob requisition id: R85152**Life Unlimited.** At Smith+Nephew, we design and manufacture technology that takes the limits off living!**About the role**Imagine a role where...

  • Regulatory Affairs Specialist

    3 semanas atrás

    São Paulo, Brasil Smith+Nephew Tempo inteiro

    Join to apply for the Regulatory Affairs Specialist (São Paulo) role at Smith+Nephew Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living! About The Role Imagine a role where you're not just part of the process, you redefine it. At the heart of our innovative medical devices' company, we’re looking for...

  • Regulatory Affairs Specialist

    Há 3 dias

    São Paulo, São Paulo, Brasil Smith+Nephew Tempo inteiro R$80.000 - R$120.000 por ano

    Life Unlimited.At Smith+Nephew, we design and manufacture technology that takes the limits off livingAbout The RoleImagine a role where you're not just part of the process, you redefine it. At the heart of our innovative medical devices' company, we're looking for a trailblazer to join our Regulatory Operations team in Brazil. This isn't your typical...

  • Regulatory Affairs Manager

    2 semanas atrás

    São Paulo, Brasil Essity Tempo inteiro

    **Regulatory Affairs Manager LATAM**: **Trabalhar na Essity não é apenas uma carreira, é uma chance de tornar o mundo um lugar mais saudável, higiênico e seguro. Com inovações impactantes, juntamente com soluções sustentáveis, nos esforçamos para alcançar mais pessoas a cada ano com as soluções necessárias e essenciais para o bem-estar.** **A...

  • Senior Regulatory Affairs Specialist

    2 semanas atrás

    São Paulo, Brasil Monster Beverage Corporation Tempo inteiro

    Forget about blending in. That's not our style. We're the risk-takers, the trailblazers, the game-changers. We're not perfect, and we don't pretend to be. We're raw, unfiltered, and a bit unconventional. But our drive is unrivaled, just like our athletes. The power is in your hands to define what success looks like and where you want to take your career....

  • Regulatory Affairs Intern

    4 semanas atrás

    São Paulo, Brasil Edwards Lifesciences Tempo inteiro

    **How you'll make an impact**:Support the Regulatory Affairs LATAM (Latin America) team by performing activities such as:- Preparation of documentation for regulatory submissions- Requesting legal documents- Processing Regulatory Affairs suppliers payments requests- Tracking timelines and document milestone achievements- Interacting with different...