Associate Director, Regulatory Data Quality
Core
Implement and operationalize data quality stewardship capabilities across Regulatory Affairs to ensure data integrity, consistency, and compliance with global regulatory requirements.
Role type
Senior IC data governance leader (Regulatory Affairs)
Builds
Authoritative regulatory datasets, governance frameworks, and data quality monitoring tools
Domain
Life Sciences / Biopharma / Regulatory Affairs
Required skills
Data governance strategy, Data stewardship, Regulatory compliance (FDA/EMA/ICH), Cross-functional leadership, Change management, KPI development, Master data management, Digital innovation, Strategic relationship building, Analytical abilities
Preferred skills
PMP certification, Change management certification, Six Sigma/Lean certification
Technologies
Veeva, Docubridge, Collibra, Informatica
Responsibilities
Operationalize the Regulatory Affairs Data Stewardship framework and standards; Support the Regulatory Affairs Data Governance Council; Evolve the design and implementation of a comprehensive data governance framework; Partner with regulatory subject matter experts to document business definitions and data standards; Ensure all regulatory data adheres to local, regional, and global compliance requirements; Evaluate and implement data quality management tools and technologies; Develop and track key performance indicators (KPIs) to measure the effectiveness of data governance initiatives.
Seniority
Senior, hands-on IC with strategic influence