Operations and Support Associate - Regulatory

Job Summary


Role Responsibilities

• Provides input and support on queries from business regarding regulatory and related systems functionality as assigned.
• Gather user requirements and identify impacts on other components of the system environment.
• Work in close collaboration with Operations and Support colleagues to provide input on impact of enhancements and change requests across all systems.
• Accountable for resolving and escalating applicable incidents, act upon user requests in collaboration with Tech colleagues as necessary.
• Contribute to discussions with business stakeholders to understand business requirements, enhancements, and product roadmap, support the documentation of internal processes, user requirements, written standards, communications and training development and content.
• Participate in all aspects of informal testing and formal user acceptance testing for releases and changes.
• Support internal and external audits and HA and LP inspection requests as needed.
• Provide user guidance and support including access and incident management tasks.
• Responsible for management of organization, personnel and product profiles.
• Responsible for configuration of PV reporting rules for Health Authorities and License Partners.
• Provide consultation and troubleshooting support for user issues, document management, system management and other problems.

Location


Basic Qualifications

• Bachelor's degree in life sciences or information technology or other related area.
• 8-10 minimum years pharmaceutical industry and/or consumer goods industry knowledge and experience.
• Experience with Veeva Vault RIMS configuration or equivalent RIM systems.
• Experience in regulatory operations, submissions or publishing systems.
• Experience in regulatory data management and lifecycle processes.
• Understanding of GxP computer system validation (CSV) principles as applied to configuration changes in a regulated environment.
• Strong troubleshooting and root-cause analysis skills, with the ability to manage and support tickets.
• Knowledge in Regulatory requirements and submissions across EU, US and Global markets.
• Experience of working within Agile delivery methodology with an understanding of the system development life cycle a plus.
• Knowledge of JIRA backlog and requirement management.
• Support user testing and execution oversight.
• Track record of success in continuous improvement, innovative work practices and driving change.
• Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels.
• Customer service orientation and ability to communicate professionally to diverse cross-functional non-technical and technical audiences.
• Experience in work requiring attention to detail and excellent follow-up.
• Self-motivated, able to resolve issues with cross-functional teams with minimal supervision.

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