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Duties: Provide support and expertise in the operations and maintenance of business-critical Global Regulatory Affairs applications. Lead the day-to-day business administration of the Regulatory Systems, including but not limited to user management, issue escalation and resolution, and system training. Collaborate closely with IT Partners and Business Owners in systems management, development, and data and process governance adherence. Drive the documentation, update, and maintenance of the Standard Operating Procedures (SOP) and Work Instructions (WI) for the applicable Regulatory Systems in the SharePoint sites. Liaising with 4 third-party vendors for the product updated updates, patches, licenses, and other SLA/KPI monitoring. Interact with multiple cross-functional teams including, but not limited to IT QA, Validation, and Infrastructure teams for compliance with Regulatory framework and documentation processes. Support multiple internal/external regulatory audits and inspections from health authorities like FDA, Health Canada, EMA, and MHRA. Analyze the customer requirements and work with the offshore team on the design and development of the desired solutions. Regular communications and meetings with business owners and other stakeholders, providing reporting and communication, and reviewing their feedback on the quality of deliverables. Travel is required 10% of the time.

Requirements: Bachelor's degree in Computer Science, Information Systems or related field plus 7 years of experience. 7 years of experience providing support and expertise in the operations and maintenance of business-critical Global Regulatory Affairs applications. 7 years of experience with leading the day-to-day business administration of the Regulatory Systems, including but not limited to user management, issue escalation and resolution, and system training. 7 years of experience with driving the documentation, update, and maintenance of the Standard Operating Procedures (SOP) and Work Instructions (WI) for the applicable Regulatory Systems in the SharePoint sites. 7 years of experience interacting with multiple cross-functional teams including, but not limited to IT QA, Validation, and Infrastructure teams for compliance with Regulatory framework and documentation processes. 7 years of experience analyzing customer requirements and working with the offshore team on the design and development of the desired solutions. 5 years of experience collaborating closely with IT Partners and Business Owners in systems management, development, and data and process governance adherence. 5 years of experience with liaising with 4 third-party vendors for the product updated updates, patches, licenses, and other SLA/KPI monitoring. 5 years of experience supporting multiple internal/external regulatory audits and inspections from health authorities like FDA, Health Canada, EMA, and MHRA. 5 years of experience with regular communications and meetings with business owners and other stakeholders, providing reporting and communication, and reviewing their feedback on the quality of deliverables.

40 hours/week. Must also have authority to work permanently in the U.S. Applicants who are interested in this position may apply at https://www.jobpostingtoday.com/ Ref #67005.