Manager, Regulatory Data and Content, Regulatory Affairs CMC
Core
Operational data steward for CMC Regulatory Affairs, ensuring data quality, governance, and lifecycle management of critical regulatory data.
Role type
Manager, Regulatory Data and Content
Builds
Structured, governed, and AI-ready regulatory data and content for CMC submissions
Domain
Pharmaceutical/Biotechnology, Regulatory Affairs, Data Governance
Required skills
Data stewardship, data quality management, regulatory data governance, process development, system testing, data remediation, master data management, requirements analysis, user acceptance testing, data metrics
Preferred skills
Life sciences background, data management experience, regulated environment experience, attention to detail
Technologies
Enterprise regulatory systems, digital enablement platforms, analytics tools
Responsibilities
Perform data entry, maintenance, and lifecycle management of regulatory data; conduct data quality reviews and resolve discrepancies; support data governance frameworks and standards; partner with IT and Digital Enablement on system implementations; develop data definitions and business rules; improve data flows and automate manual activities.
Seniority
Manager, hands-on IC with strategic input