Director, Regulatory Affairs Data Standards and Governance
Core
Drive implementation of regulatory data standards and governance to support data submissions and enable data connection across R&D, Supply Chain, Operations, and Quality Assurance functions.
Role type
Director, Regulatory Data Governance & Standards
Builds
Enterprise-level data governance processes, data catalogs, ontologies, and system dictionaries for regulatory interoperability.
Domain
Life Sciences / Regulatory Affairs / Data Governance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data governance, regulatory data standards (FDA, EMA, WHO, ICH), ISO IDMP, data catalog management, ontology services, system dictionary management, cross-functional collaboration, industry forum advocacy
Preferred skills
Regulatory affairs strategy, electronic regulatory submissions, master data governance projects, business SME in regulatory applications
Technologies
COSMOS RIM, Hubble, SPOR platform, eCTD4, FHIR
Responsibilities
Build and execute lean data governance processes; define and implement consistent data standards across the enterprise; advocate for company interests in external industry forums; collaborate on central ontology services; support rollout and training of analysis tools for data harmonization; monitor and maintain system dictionaries and vocabularies; deliver system releases to drive automation and data optimization.
Seniority
Director, strategic leadership & cross-functional execution
