Mid-Level, Senior
Want to be the hands-on technical owner of regulatory submission and Regulatory Information Management (RIM) platforms at a Fortune 500 company, building and configuring the technology that enables products to be brought to market and maintained with regulatory authorities? If this sounds exciting to you, we want to speak with you! We are looking for hands-on system administration and configuration experience supporting regulated enterprise platforms. This position is in Richmond, VA with a hybrid work schedule. Relocation benefits will be provided.
As an Associate Manager, Technology - Regulatory Affairs, you will join the Technology Delivery team supporting the Regulatory Affairs organization. This role serves as the primary technical resource for regulatory technology platforms, responsible for system administration, configuration, validation, support, and continuous enhancement of solutions that support regulatory operations and compliance.
What you will be doing:
Configuring and building Regulatory Affairs technology solutions, including Regulatory Information Management (RIM), submission planning and publishing, and regulated content management platforms.
Coordinating user access, roles, groups, permissions, and security controls to ensure compliance with governance, segregation-of-duties, and access management requirements.
Leading application environments, release cycles, configuration migrations, vendor upgrades, and deployment activities across development, test, and production instances.
Driving testing, validation, defect resolution, deployment readiness, and hypercare activities to support successful implementation of technology enhancements.
Maintaining integrations and data interfaces between regulatory platforms and connected enterprise systems while solving technical issues and reconciling data discrepancies.
Performing data administration activities, including bulk loads, migrations, mass updates, data remediation, and quality improvement initiatives supporting regulatory operations.
Supporting compliance, audit, and validation requirements by developing and carrying out documentation aligned with SDLC, Computer System Validation (CSV), Quality Management System (QMS), and process improvement procedures.
Collaborating with Regulatory Affairs partners, technology teams, vendors, and consulting partners to deliver improvements, resolve issues, and enable adoption of new capabilities.
We want you to have:
Bachelor's degree in Information Systems, Computer Technology, Life Sciences, or a related field, or equivalent professional experience.
5+ years in Information Systems and Technologies, or a combination of technology and business experience.
Hands-on experience coordinating and configuring enterprise applications within validated, regulated, or controlled environments.
Experience delivering technology projects and system enhancements from requirements definition through deployment and production support.
Experience supporting Regulatory Affairs technology, including Regulatory Information Management (RIM) solutions, regulatory submission processes, or regulated content management platforms.
Knowledge of system security administration, environment management, release management, configuration migration, testing, and technical troubleshooting practices.
Familiarity with SDLC methodologies, Computer System Validation (CSV), organizational change processes, and regulatory compliance requirements including 21 CFR Part 11.
Strong analytical, problem-solving, integration, data management, and reporting capabilities, with the ability to work independently and drive issues to resolution.
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