Regulatory Affairs Strategist, Digitalization - Advertising & Promotion
Core
Business owner for global Advertising & Promotion digital platforms, ensuring regulatory compliance, system governance, and lifecycle management for MedTech promotional activities.
Role type
Senior Regulatory Affairs Strategist (Digitalization)
Builds
Scalable digital capabilities for global Advertising & Promotion regulatory processes
Domain
Medical Technology / Regulatory Affairs / Digital Systems
Required skills
Regulatory Affairs lifecycle management, Computer Systems Validation (CSV), Software Development Lifecycle (SDLC), business requirements translation, application governance, data integrity management, stakeholder partnership, change control, training strategy development, GxP compliance
Preferred skills
Advertising & Promotion regulatory processes, Veeva platform experience, global matrixed organization experience, AI-enabled capabilities implementation
Technologies
Veeva, SDLC tools, CSV tools, eLearning platforms
Responsibilities
Manage global Ad/Promo digital platform roadmap and continuous improvement; Translate regulatory policies into scalable system requirements and workflows; Lead release and change management with validation controls; Author and approve business-owned application documentation (SOPs, work instructions); Lead business test planning, execution, and approval for SDLC and validation activities; Establish and monitor application metrics for performance and data quality.
Seniority
Senior, hands-on IC