Director Structured Content Authoring- Regulatory Affairs
Core
Establish vision, strategy, and governance for transforming regulatory operations from document-centric to a data-driven, component-based model using structured content and master data.
Role type
Director, Structured Content Authoring & Regulatory Data Governance
Builds
Integrated enterprise capability for structured regulatory content, IDMP data governance, and master data management supporting global compliance.
Domain
Life Sciences / Regulatory Affairs / Data Governance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, Regulatory data governance, IDMP expertise, Information architecture, Digital transformation, Stakeholder alignment
Preferred skills
Veeva Vault RIM, Structured Content Authoring platforms, Knowledge graphs, FHIR, Automation technologies, Industry standards forums
Technologies
Veeva Vault RIM, Structured Content Authoring platforms, Data catalogues, Knowledge graphs, FHIR, RIM platforms, Publishing platforms, AI-enabled capabilities
Responsibilities
Establish governance structures, ownership models, and quality standards for regulatory content and data; Oversee reusable content components for labelling, CMC, clinical, and submission content; Provide strategic leadership for IDMP governance; Shape future-state architecture connecting RIM platforms and data engineering teams; Ensure automation and AI are grounded in trusted, governed content.
Seniority
Director, Strategic Leadership & Cross-functional Alignment
