Regulatory Affairs Senior Manager, Regulatory Information & Content Management

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Senior Manager, Regulatory Information & Content Management is responsible for developing, executing, and maintaining the global Regulatory Affairs strategy and roadmap for regulatory information, regulatory content, and the digital platforms that support their management across Business Units and Regions, in alignment with the broader Digital RA strategy and with specific responsibility for the Regulatory Information Management System (RIM).

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.

Through effective communication, cross-functional collaboration, and problem-solving, the Senior Manager partners with the Senior Director, RA Digitalization, and other leaders to advance the Digital RA strategy, identify transformative opportunities, and lead high-impact initiatives that improve regulatory effectiveness and strengthen BD’s quality standards and customer trust.

• →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 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.

•         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.

• 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.

• 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.

• Regulatory Information and Content Management: Demonstrates strong understanding of regulatory information management, document and submission management, content lifecycle management, metadata and taxonomy, information governance, and emerging approaches for connecting structured and unstructured regulatory information. Understands how well-governed regulatory information and content enable analytics, automation, and responsible AI-enabled capabilities.
• Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
• Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
• Decision Quality: Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives with clearly documented consequences for each possible course of action.
• Communication Skills: Skilled facilitator for small and large groups and organizations, adapting content and style to engage audiences, and able to articulately respond to impromptu comments and questions.
• Action Oriented: Demonstrates a significant bias for action to execute key objectives, while actively seeking other opportunities to contribute.  
• Courage & Independence: Seeks out and selects stimulating work with challenges, increasing scope and responsibilities.
• Composure: Responds constructively in stressful situations and effectively calms others while taking action to resolve the root cause of the situation causing stress. 
• Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management.
• Process Effectiveness: Independently identifies the most efficient way to simplify and implement complex processes.
• Process and Service Acumen: Thorough understanding of service-related processes and service engineering with ability to independently influence organizational direction.
• Organizational Agility: Is cognizant of organizational culture in a matrixed environment and appropriately adjusts personal style to be effective. Builds numerous and beneficial relationships through personal networks, inside and outside the organization. 
• Influencing Others: Leverages internal or external experts or third parties to influence others towards an intended course of action. Experienced at using multiple chains of influence to achieve broad organizational acceptance.
• Dealing with Ambiguity: Anticipates the organizational impact of change, rising to the challenge, applying ingenuity, while accepting risk and uncertainty as normal.
• Building Effective Teams: Builds mission-driven, cohesive teams of people, sharing team wins and successes throughout the organization to instill team member value and appreciation.