• Define vision for Regulatory Operations, build scalable infrastructure, mentor teams, and provide solutions balancing compliance with business needs. • Oversee lifecycle of submissions, from planning, formatting, publishing (eCTD), to archiving, managing health authority correspondence and commitments. • Implement internal US eCTD submission and Regulatory Information systems including regulatory document templates. • Drive continuous improvement, implement best practices, and develop standard operating procedures for efficient, lean operations. • Partner with Regulatory Affairs, R&D, Quality, and Commercial teams to ensure integrated, compliant product development. • Monitor global regulatory changes, assess impact, and advise leadership on strategy adjustments. • Oversee relationships with external vendors and contractors for systems and technology.