Director, Regulatory Affairs-CMC

Role: Lead and strategize global Content Management and Digital Enablement for CMC regulatory content, ensuring compliance, efficiency, and digital modernization. Responsibilities: define content lifecycle strategies, establish governance and standards, drive operational excellence, implement digital tools and AI-enabled solutions, and support CMC regulatory submission processes through cross-functional collaboration. Requirements: Bachelor's degree (advanced in Life Sciences, Regulatory, or IS preferred), extensive experience in regulatory content management within biopharma, proven leadership in strategy and process improvement, familiarity with platforms like Veeva Vault and Power BI, and strong stakeholder management skills. High-Value: focus on CMC content, regulatory lifecycle, digital transformation, inspection readiness, global compliance, and platforms supporting structured, modular content. WorkSetup: hybrid, with no travel required.