Sr. Staff RIMS Platform Owner [Remote]

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Staff RIMS Platform Owner based in United States.

This role sits at the intersection of regulatory strategy, enterprise systems, and digital transformation within a highly regulated life sciences environment. You will own the end-to-end vision and lifecycle of a global Regulatory Information Management System (RIMS) platform, ensuring it supports scalable, compliant, and efficient regulatory operations. The position plays a critical role in connecting Regulatory Affairs, Quality, and IT to modernize workflows across multiple business units. You will drive platform governance, system validation, and continuous improvement while shaping the future of regulatory technology. A key aspect of the role is embedding automation and AI capabilities to streamline regulatory processes and enable data-driven decision-making. Operating in a cross-functional and global context, you will influence both strategy and execution. This is a high-impact role for someone who thrives in complex, regulated, and transformation-focused environments.

Accountabilities

You will serve as the enterprise owner of the RIMS platform, defining its roadmap, ensuring compliance, and enabling scalable digital regulatory operations across the organization. You will also act as the key bridge between business stakeholders, IT, and vendors to ensure seamless execution and continuous improvement.

• Own the end-to-end RIMS platform lifecycle, including requirements, configuration, validation, deployment, and ongoing optimization
• Define and execute the global RIMS roadmap aligned with regulatory strategy and digital transformation goals
• Ensure system compliance with GxP, 21 CFR Part 11, and CSV requirements, maintaining validated state across all changes
• Harmonize regulatory workflows across multiple operating units to ensure consistency and global alignment
• Lead integration of AI, automation, and intelligent agents to improve efficiency and decision-making in regulatory processes
• Partner with Regulatory Affairs, Quality, and IT teams to translate business needs into scalable system capabilities
• Oversee vendor relationships and ensure delivery of platform enhancements and system stability
• Drive continuous improvement initiatives across regulatory systems, data flows, and reporting capabilities

Requirements

This role requires deep experience in regulated environments, strong ownership of enterprise systems, and the ability to translate complex regulatory needs into scalable technology solutions.

• Bachelor’s degree with 14+ years of experience, or Master’s/PhD with 12+ years in regulated industry environments
• Proven experience as a systems owner, business analyst, or platform lead within Regulatory Affairs or Quality functions
• Strong knowledge of RIMS and/or eQMS platforms (e.g., MasterControl, Veeva, SmartSolve, Regdesk, or similar)
• Solid understanding of GxP regulations, 21 CFR Part 11, and computer systems validation (CSV) principles
• Experience leading large-scale digital transformation or enterprise platform implementations
• Ability to manage cross-functional stakeholders across regulatory, IT, and business teams
• Strong analytical, problem-solving, and communication skills with executive-level influence
• Experience working in FDA-regulated industries such as diagnostics, medical devices, or life sciences preferred
• Exposure to AI/automation initiatives within enterprise systems is a strong plus

Benefits

• Competitive annual base salary around $165,000 – $175,000 USD
• Eligibility for annual bonus and incentive compensation programs
• Comprehensive medical, dental, and vision insurance coverage
• 401(k) retirement savings plan with employer contributions (where applicable)
• Paid time off, holidays, and flexible leave policies
• Remote work flexibility depending on location and business needs
• Access to continuous learning and professional development opportunities
• Inclusive, innovation-driven environment focused on digital transformation

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.