Regulatory Affairs Associate Specialist, International Labeling Support (ILS)
Core
Supports cross-functional collaboration to plan, coordinate, and execute regulatory operational activities for labeling and artwork packages, ensuring timely and compliant delivery.
Role type
Entry-level Regulatory Affairs Associate Specialist (International Labeling Support)
Builds
High-quality labeling and artwork packages aligned with company requirements
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory Compliance, Regulatory Processes, Support Coordination, Database Maintenance, Record Filing, Process Documentation, Process Improvement, Project Coordination, Change Management, Liaison with Country Regulatory Affairs
Preferred skills
Awareness of Regulatory Affairs, Labeling, Artwork, Quality, Compliance, Pharmaceutical Operations, Microsoft 365 proficiency, Automation support
Responsibilities
Prepare labeling and artwork packages, support Country Regulatory Affairs with database maintenance and record filing, engage on labeling/artwork queries, assist with process documentation updates, contribute to process improvement initiatives, support follow-ups and escalations for submissions/approvals, collect inputs for planning labeling/artwork business processes, assist with cross-functional projects involving labeling/artwork changes
Seniority
Entry-level, hands-on IC
