Director, Regulatory Affairs-CMC

Role: Lead the global CMC content management strategy and digital enablement, serving as subject matter expert to modernize content lifecycle processes, ensure compliance, and enable digital tools and AI-driven solutions. Responsibilities: define governance, standards, and operating procedures; lead process improvements for content quality, reuse, and audit readiness; oversee digital tool implementation (e.g., Veeva Vault, Lorenz docuBridge, Power BI); collaborate with Regulatory, Quality, IT, and Business stakeholders; develop KPIs and dashboards for content performance; mentor teams and influence cross-functional partners. Requirements: Bachelor's in Life Sciences, Regulatory, or related field; extensive experience in CMC content management, regulatory operations, or pharma with expertise in structured content, metadata, lifecycle management, and digital transformation; proven leadership in strategy and governance; strong stakeholder management and communication skills. Preferred: experience with digital platforms, global submission support, and operational process design. HighValue: CMC content management, digital enablement, regulatory compliance, inspection readiness, global pharma environment, cross-functional collaboration, system platforms (Veeva Vault, Lorenz docuBridge). WorkSetup: hybrid, no travel required.