Regulatory Affairs Senior Manager, Regulatory Information & Content Management

This role leads the Regulatory Information and Content Management components of the comprehensive Digital RA roadmap and portfolio, improving the accessibility, connectivity, quality, reuse, traceability, and lifecycle management of regulatory information and content and enabling more effective regulatory execution and data-driven decision-making.

The Senior Manager provides strategic and operational leadership for assigned Regulatory Affairs platforms and capabilities, including Regulatory Information Management and systems supporting regulatory document and submission management.

The role leads development and execution of the Regulatory Content Management strategy, establishing the capabilities and governance necessary to make authoritative regulatory content findable, connected, reusable, traceable, and suitable for emerging AI-enabled regulatory use cases.

The Senior Manager partners with SMEs and stakeholders across Central Regulatory Affairs, Business Units, Regions, TGS, Quality, and other functions to identify user and business needs and translate them into scalable information, content, and platform capabilities.

Job Responsibilities

• Lead Global Regulatory Information and Content Management: Provide strategic and operational leadership for global regulatory information, regulatory content, digital capabilities supporting document and submission management, and assigned digital platforms, ensuring alignment with regulatory strategy, business needs, and the broader Digital RA roadmap.
• Contribute to the Global RA Digital Strategy: Partner with the Senior Director, RA Digitalization, and Regulatory and technology leaders to identify strategic opportunities and ensure Regulatory Information and Content Management priorities are appropriately represented in the broader Digital RA strategy and portfolio.
• Own and Execute the Capability Roadmap: Translate the Regulatory Information and Content Management strategy into prioritized global capabilities and initiatives aligned with enterprise priorities and the needs of Business Units and Regions.
• Lead the Regulatory Information and Content Management Portfolio: Oversee prioritization and execution of assigned RIM, content management, document and submission management, and information management initiatives, ensuring stakeholder alignment, disciplined delivery, and measurable outcomes.
• Develop Strategic Initiatives and Business Cases: Assess business needs, performance information, external practices, technology trends, expected value, dependencies, risks, and resource requirements to recommend and advance strategic initiatives within the Regulatory Information and Content Management portfolio.
• Provide Business Ownership for Assigned Platforms: Establish business priorities, requirements, governance, lifecycle expectations, and performance measures for assigned global Regulatory Affairs platforms and capabilities.
• Build Cross-Functional Partnerships: Partner with TGS, ISC, Quality, Central Regulatory Affairs, Business Units, Regions, and other stakeholders to design, implement, operate, and continuously improve scalable information, content, and platform capabilities.
• Define Goals and Performance Measures: Establish measurable goals and outcomes for the Regulatory Information and Content Management portfolio and monitor platform and capability performance, adoption, information and content quality, user experience, and business value.
• Lead Platform and Capability Optimization: Identify and implement opportunities to improve the flexibility, scalability, usability, integration, and operational effectiveness of assigned platforms and related business processes.
• Lead the Regulatory Information and Content Management Strategy: Define the global strategy and future-state capability model for managing regulatory information and content across its lifecycle, including the relationships among RIM, document and submission management, authoritative content sources, and related digital capabilities.
• Establish Regulatory Information and Content Architecture: Define business requirements and governance expectations for information models, taxonomy, metadata, classification, relationships, ownership, lifecycle, traceability, and authoritative sources.
• Enable Regulatory Content Discovery and Reuse: Lead capabilities that allow regulatory users to discover, retrieve, contextualize, and, where appropriate, reuse approved regulatory content, prior submissions, regulatory correspondence, and supporting evidence.
• Connect Regulatory Information and Content: Advance integration between structured regulatory information and unstructured regulatory content so content can be understood in the context of products, markets, registrations, submissions, regulatory activities, and health-authority interactions.
• Improve Information and Content Quality: Establish appropriate ownership, stewardship, quality expectations, and performance measures to improve the completeness, consistency, usability, and reliability of regulatory information and content.
• Enable AI-Ready Regulatory Information and Content: Establish the information architecture, quality, governance, metadata, and content management foundations necessary to support responsible AI-enabled capabilities, including intelligent search, retrieval, comparison, impact assessment, decision support, and AI-assisted content development.
• Partner on AI-Enabled Regulatory Capabilities: Partner with Regulatory AI Enablement and Data Products leadership, TGS, SMEs, and process owners to develop and scale AI-enabled capabilities that use trusted regulatory information and content while maintaining appropriate regulatory, quality, privacy, security, and governance controls.
• Provide Regulatory Affairs business leadership and governance for SDLC activities associated with assigned platforms and capabilities, ensuring appropriate requirements, testing, validation, deployment readiness, and lifecycle controls.
• Ensure appropriate business involvement in test strategy, test planning, user acceptance testing, performance qualification, and implementation readiness.
• Review and provide business approval of applicable SDLC deliverables, ensuring alignment among user requirements, business processes, system design, intended use, and applicable controls.
• Ensure appropriate business participation in regression testing for platform enhancements, periodic releases, and infrastructure upgrades.
• Partner with Quality and technology organizations to establish fit-for-purpose CSV and validation strategies for assigned regulatory platforms and enhancements.
• Establish appropriate governance for platform demand, enhancement prioritization, release planning, issue escalation, and lifecycle management.
• Lead assigned Regulatory Information and Content Management resources, including goal setting, coaching, talent development, performance management, resource planning, and capability development.
• Manage assigned operating budgets and contribute to business cases, investment planning, resource forecasts, and project and technology funding recommendations for the Regulatory Information and Content Management portfolio.
• Provide direction to cross-functional project teams, business SMEs, contractors, and external partners supporting assigned platforms and initiatives.

Minimum Requirements

• Bachelor’s degree in science, engineering, technology, information management, business, or a related discipline.
• Minimum of 8 years of progressive experience in Regulatory Affairs, Quality, regulatory operations, information/content management, digital technology, business systems, or a related discipline.
• Demonstrated experience leading Regulatory Information Management, content management, document and submission management, regulatory product information management, or a related enterprise digital capability in a regulated environment.
• Demonstrated experience leading and developing employees and/or globally distributed teams.
• Demonstrated experience partnering with technology organizations to implement, govern, enhance, or maintain business systems.
• Experience translating regulatory and business needs into information, content, process, data, or technology requirements.
• Experience leading complex, cross-functional initiatives in a global or matrixed organization.
• Working experience with applicable SDLC, validation, data integrity, and regulated-system controls.

Preferred Qualifications

• Master’s degree in business, management, information science, technology, regulatory affairs, or a related discipline.
• Experience within the medical device or life sciences industry.
• Experience serving as a business owner or capability leader for an enterprise regulatory platform.
• Experience with RIM, document and submission management, structured product information, regulatory content management, taxonomy, metadata, or information governance.
• Experience managing budgets, vendors, external partners, or globally distributed resources.
• Regulatory Affairs Certification or a relevant information, data, project, or technology credential.