Director Structured Content Authoring- Regulatory Affairs

Overview

As Director of Structured Content Authoring, you will lead the move from document-centric regulatory operations to a data-driven, component-based model. You’ll set vision, governance and a roadmap that links regulatory content, master data, and enterprise data governance to deliver reusable, traceable information assets for global compliance and digital health needs. You’ll drive an integrated capability across content, IDMP data governance, master data, terminology, metadata and information architecture, working with cross-functional teams to align strategy and investment. You’ll shape future-state architecture and ensure AI-enabled capabilities rest on trusted data and content.

Responsibilities

• Establish governance structures, ownership models, decision rights, quality standards and stewardship across regulatory content and data domains
• Oversee reusable content components and data assets across labelling, CMC, clinical and submission content for lifecycle traceability and reuse
• Provide strategic leadership for IDMP governance covering product, substance, organisation, referential, registration, manufacturing and packaging data
• Collaborate with Regulatory Technology, enterprise architecture and data engineering to shape future-state architecture connecting RIM platforms, content solutions, master data, terminology services, publishing, analytics and AI
• Ensure automation, AI and advanced regulatory technologies are grounded in governed and traceable content and data

Key requirements

• Substantial life sciences experience with regulatory data governance, IDMP, RIM platforms, master data management, information architecture and digital transformation
• Strong understanding of global regulatory standards (ISO IDMP, XEVMPD/Article 57, EMA SPOR) is highly desirable
• Experience with Veeva Vault RIM and Structured Content Authoring platforms, data catalogues, knowledge graphs, FHIR, automation technologies; participation in industry standards forums is advantageous
• Proven ability to establish governance frameworks, operating models and data standards supporting regulatory compliance, data quality, content reuse and operational excellence
• Strong strategic leadership, executive communication and cross-functional stakeholder management abilities

• Collaborative leadership
• Strategic influence
• Stakeholder management
• Veeva Vault RIM
• Structured Content Authoring platforms
• Data catalogues

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