Regulatory Affairs Associate Specialist, International Labeling Support (ILS)
Core
Support cross-functional collaboration to plan, coordinate, and execute labeling and artwork regulatory operational activities ensuring timely, accurate, and compliant execution.
Role type
Entry-level Regulatory Affairs Associate Specialist (International Labeling Support)
Builds
Labeling and artwork packages for global regulatory submissions
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Regulatory Compliance, Regulatory Submissions, eCTD, Support Coordination, Process Documentation, Database Maintenance, Record Filing, Operational Support, Cross-functional Collaboration, Process Improvement
Preferred skills
Pharmaceutical industry experience, Regulatory Affairs awareness, Microsoft 365 proficiency, Automation support, Multicultural collaboration
Technologies
Microsoft 365 (Outlook, Excel, PowerPoint, Teams, SharePoint), eCTD
Responsibilities
Prepare high-quality 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 escalation information for submissions; collect country requirements for planning; assist with cross-functional projects involving labeling changes.
Seniority
Entry-level, hands-on IC