Director, Structured Content Authoring – Regulatory Affairs

About the role

The Director, Structured Content Authoring is a transformational leadership role responsible for accelerating the organisation's evolution from document‑centric regulatory operations to a modern, data‑driven and component‑based operating model.

Key responsibilities

• Establish governance structures, ownership models, decision rights, quality standards and stewardship practices across regulatory content and data domains.
• Oversee reusable content components and data assets covering labelling, CMC, clinical and submission content, ensuring efficient creation, approval, maintenance, reuse and traceability throughout the product lifecycle.
• Provide strategic leadership for IDMP governance, aligning product, substance, organisation, referential, registration, manufacturing and packaging data with global regulatory standards.
• Shape future‑state architecture connecting RIM platforms, structured content solutions, master data management, terminology services, publishing platforms, analytics and AI‑enabled capabilities.

Required profile

• Extensive life‑science experience with a proven track record in regulatory data governance, IDMP, RIM platforms, master data management and digital transformation.
• Strong understanding of global regulatory standards such as ISO IDMP, XEVMPD/Article 57 and EMA SPOR.
• Experience establishing governance frameworks, operating models and data standards that support compliance, data quality and content reuse.
• Executive‑level communication and stakeholder‑management skills with the ability to influence across complex, cross‑functional organisations.

Required skills

• Veeva Vault RIM
• Structured Content Authoring platforms
• Data catalogues
• Knowledge graphs
• FHIR
• Automation technologies