Regulatory Affairs Professional
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of the Global Development Information Management group, you will play a crucial role in enhancing compliance and efficiency within the organization.
* Identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform.
* Collaborate closely with cross-functional stakeholders such as IT, Clinical, Nonclinical, Quality, Global Regulatory Operations (GRO), and Global Regulatory Affairs (GRA).
* Support RIM Reporting and Analytics needs across Global Regulatory Affairs as needed.
In this role, you will contribute to implementing a RIM enterprise data strategy, including E2E RIM implementation, system changes, upgrades, integrations, data quality, metrics & reporting, etc. You will document user requirements 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.
You will track alignment of business processes and models across all business functions supporting global Regulatory product registrations. Lead initiatives to integrate Regulatory information and records globally and for acquired assets and products. Monitor emerging structured data standards or health agency requirements and assess their impact on the business. Define a roadmap for addressing these requirements.
Requirements
* 6+ years of working in biotechnology or pharmaceutical Regulatory Affairs Operations, systems management or implementation in the life sciences industry.
* Veeva Vault RIM experience is required. Microsoft Office and Adobe systems are also preferred.
* Familiarity with regulations, processes, and industry standards, as well as knowledge of best practices that govern regulated systems, records retention, and GxP is essential.
About This Role
This is an exciting opportunity to join our team and contribute to shaping the future of Regulatory Affairs. If you have a passion for regulatory compliance and data management, we encourage you to apply.