Specialist, International Labeling Support
Core
Partner cross-functionally to plan, manage, and execute regulatory labeling and artwork activities, ensuring compliance and operational excellence.
Role type
Specialist, International Labeling Support (Regulatory Operations)
Builds
High-quality labeling and artwork packages aligned with company requirements
Domain
Pharmaceutical Regulatory Affairs / Life Sciences
Deliverable
product features
Required skills
Regulatory Affairs Compliance, Process Documentation, Database Management, Operational Excellence, Continuous Process Improvement, Detail-Oriented, Microsoft 365
Preferred skills
Electronic Records Management (ERM), Regulatory Systems, Quality Assurance Compliance, Project Planning, Training Instruction
Responsibilities
Prepare high-quality labeling and artwork packages; maintain regulatory records and databases; support Country Regulatory Affairs (CRA) activities; ensure deliverables are completed accurately and on time; collaborate with stakeholders to resolve queries; update process documentation and training materials.
Seniority
Specialist, hands-on IC
