A company is looking for a Manager, Regulatory Information Management.
Key Responsibilities
Advise on centralized regulatory business systems operations and monitor data standards
Support centralized data services within RIM capabilities and provide data reporting for the Regulatory department
Collaborate with IT and cross-functional teams to document business requirements for regulatory solutions
Required Qualifications
5+ years of experience in Pharmaceutical, Bio-Technology, or Life Sciences with a focus on Regulatory
3+ years of experience in Regulatory Information Management (RIM) or similar operations in GxP / Regulated Systems
Working knowledge of applicable Regulatory Agency regulations and guidelines (e.g., FDA / EMA, ICH, eCTD)
Manager Information • Hialeah, Florida, United States