Data & Conformance Manager, Associate
Core
Interpret, manage, and ensure the quality and accuracy of global regulatory data and conformance activities across geographies and functions to enable data integrity throughout the product lifecycle.
Role type
Regulatory data and conformance manager
Builds
Regulatory data systems and dossiers
Domain
Life sciences / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Regulatory data interpretation, system updates, data entry, quality control, SOP adherence, decision making within guidelines
Preferred skills
Global regulatory initiatives support, internal process documentation, ad-hoc metrics review
Technologies
Corporate change and dossier management systems, global regulatory systems
Responsibilities
Review and interpret data to establish required system/tool population; Maintain HA status in corporate change and dossier management systems; Update regulatory systems for CMC events upon submission/approval notification; Perform data entry and quality control in global regulatory systems; Support teams with data management workload; Assist in documenting internal regulatory processes; Support ad-hoc activities including metrics review and presentations
Seniority
Mid-level, hands-on IC