Job DescriptionThe Regulatory Affairs Strategist, Digitalization - Advertising & Promotion is responsible for the business ownership, lifecycle management, and continuous improvement of digital platforms supporting global Advertising & Promotion regulatory activities. This role ensures that digital solutions effectively support regulatory and business processes while maintaining appropriate system governance, data integrity, validation, operational effectiveness, and user experience.
The role partners closely with the Global Advertising & Promotion Process Owner, Business Units, Regions, Central Regulatory Affairs, TGS, technology partners, and other stakeholders to translate regulatory and business requirements into scalable digital capabilities. The role manages business activities associated with platform enhancements, releases, application governance, Software Development Lifecycle (SDLC), Computer Systems Validation (CSV), testing, training, and user adoption.
As part of the Regulatory Affairs Digitalization organization, the role identifies and implements opportunities to improve efficiency, leverage AI-enabled capabilities and automation, strengthen data quality and reporting, enhance integration, and improve user experience while ensuring alignment with the broader Regulatory Affairs digital strategy.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Global Advertising & Promotion Digital Platform Ownership - Manage Global Ad/Promo Digital Platforms: Serve as the Regulatory Affairs business owner for digital platforms supporting Advertising & Promotion, providing business leadership for platform operations, lifecycle management, enhancements, releases, and continuous improvement.
- Partner with the Global Ad/Promo Process Owner: Translate global Advertising & Promotion policies, procedures, process requirements, and regulatory needs established through the global process governance model into scalable system requirements, workflows, and digital capabilities.
- Manage Platform Roadmap and Continuous Improvement: Manage the business platform roadmap by identifying, evaluating, prioritizing, and advancing platform capabilities and improvements, including opportunities related to workflow, AI-enabled capabilities, automation, reporting, integration, data quality, and user experience, in alignment with the broader Regulatory Affairs digital roadmap.
- Lead Release and Change Management: Evaluate vendor releases, enhancements, and proposed system changes for business applicability and impact. Partner with TGS, technology partners, and stakeholders to plan and implement changes while maintaining appropriate business and validation controls.
- Drive Business Requirements: Lead the identification, documentation, and alignment of business and user requirements across Central, Business Unit, and Regional stakeholders, ensuring solutions support intended business processes and regulatory needs.
Application Governance and Sustaining Support - Provide Regulatory Affairs business governance and oversight for application configuration, business-controlled data, user access, and role design, in partnership with technology and operational teams.
- Identify data quality and integrity risks, lead or coordinate appropriate resolution and escalation, and identify recurring application issues and opportunities for systemic improvement.
- Lead Power User forums, Change Control Board activities, and other application governance mechanisms to facilitate effective communication, prioritization, and decision-making.
- Establish and monitor relevant application metrics to evaluate platform performance, effectiveness, data quality, adoption, and opportunities for continuous improvement.
- Develop business impact assessments, resource considerations, and cost and timing estimates, as appropriate, for proposed enhancements and digital initiatives.
Quality Management System and Training - Author, review, and approve applicable business-owned application documentation, including SOPs, work instructions, and other controlled documentation, partnering with the Global Ad/Promo Process Owner and relevant Quality and Regulatory stakeholders to ensure alignment with approved business processes and requirements.
- Establish and maintain the application training strategy and associated training materials.
- Coordinate the development and maintenance of learning content, including eLearning modules, work instructions, and other user-support resources.
- Drive user readiness, adoption, and effective use of the platform across Business Units and Regions.
SDLC and Validation - Lead Regulatory Affairs business activities associated with the Software Development Lifecycle and Computer Systems Validation for Advertising & Promotion digital platforms.
- Lead business test planning and execution, including Performance Qualification (PQ), User Acceptance Testing (UAT), and applicable regression testing.
- Serve as business test lead and coordinate the development, review, execution, and approval of business test scripts and associated evidence.
- Review and provide business input and approval for applicable SDLC and validation deliverables.
- Participate in key requirements, design, risk, validation, and release-readiness activities, ensuring alignment among user requirements, business processes, system design, and intended use.
- Provide business and Regulatory Affairs input into CSV/validation strategies for platform enhancements, releases, and infrastructure changes.
- Ensure appropriate business readiness prior to implementation of system changes and enhancements.
Education and Experience:- Bachelor's degree in a science, engineering, technology, health-related, or related discipline.
- Minimum of 5 years of progressive experience in Regulatory Affairs, Quality, digital/technology, business systems, or a related function.
- Minimum of 3 years of experience supporting, implementing, or managing business systems within a regulated environment.
- Demonstrated experience partnering with IT or technology organizations to implement and maintain systems following GxP, Computer Systems Validation (CSV), and Software Development Lifecycle (SDLC) standards.
- Experience with business requirements, system enhancements, application testing, release management, and validated system lifecycle activities.
- Experience working in the medical device, pharmaceutical, life sciences, or another regulated industry.
Preferred Qualifications - Master's degree in a business, management, science, engineering, or technology-related field.
- Experience supporting Regulatory Affairs digital platforms.
- Experience with Advertising & Promotion regulatory processes and/or promotional-material management platforms.
- Experience with Veeva or similar regulated content/workflow platforms.
- Experience operating in a global, matrixed organization.
Knowledge and Skills - Digital Platform and Business Systems Acumen: Demonstrated understanding of business application ownership, system lifecycle management, requirements, enhancements, releases, testing, validation, and sustaining operations.
- Regulatory and Quality Systems Knowledge: Working knowledge of regulated business environments, GxP principles, Computer Systems Validation, data integrity, and applicable quality-system requirements.
- Business Process and Requirements Management: Ability to translate complex business and regulatory needs into clear requirements, workflows, and scalable digital solutions.
- Problem Solving and Analytical Skills: Uses data, experience, technical knowledge, and sound judgment to identify root causes, evaluate alternatives, manage risk, and implement effective solutions.
- Organization and Planning: Independently manages multiple initiatives and priorities, establishes measurable objectives, and coordinates resources to deliver agreed outcomes.
- Communication: Communicates complex technical and business topics clearly to technical teams, end users, Regulatory stakeholders, and leadership.
- Cross-Functional Collaboration: Builds effective partnerships across Central Regulatory Affairs, Business Units, Regions, TGS, Quality, process owners, vendors, and other stakeholders.
- Influencing Others: Effectively influences decisions and priorities across a global matrix without relying solely on direct authority.
- Change Management and User Adoption: Effectively supports organizational and technology change through stakeholder engagement, communications, training, and user-readiness activities.
- Continuous Improvement: Proactively identifies opportunities to simplify processes, improve system effectiveness, responsibly leverage AI and automation, enhance data quality, and improve the user experience.
- Dealing with Ambiguity: Effectively assesses risk, competing priorities, and incomplete information to develop practical solutions and appropriate escalation paths.
Physical Demands (if applicable)
- When work is performed in an office environment, the position requires the ability to operate standard office equipment and keyboards. Must have the ability to stand, walk, and sit; talk or hear, both in person and by telephone; use hands to handle objects or controls; and reach with hands and arms.
- Ability to travel domestically and internationally approximately 10-20%.
Work Environment: (if applicable)
- Position follows the applicable BD workplace designation and associated on-site requirements.
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