Regulatory Affairs Specialist, International Labeling Support (ILS) (Open)
Core
Ensures timely, accurate, and compliant execution of international labeling and artwork regulatory operational activities across global regions.
Role type
Specialist, International Labeling Support (ILS)
Builds
Labeling and artwork packages aligned with company requirements and regulatory submissions
Domain
Pharmaceutical industry, Regulatory Affairs, Labeling & Artworks
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory Affairs Compliance, Regulatory Submissions, Documentation Preparation, Process Improvement, Cross-functional Collaboration, Operational Excellence, Microsoft 365 proficiency, Detail-Oriented
Preferred skills
CMC knowledge, Quality management experience, Local/regional legislation familiarity, Business process understanding
Technologies
Microsoft 365 (Excel, PowerPoint, SharePoint)
Responsibilities
Prepare high-quality labeling and artwork packages; Support database maintenance and records filings; Collaborate with Global and Country Regulatory Affairs on labeling queries; Support process documentation updates; Contribute to process re-engineering and tool simplification; Manage follow-ups and escalations for submissions and approvals; Collect country-specific inputs for labeling business processes.
Seniority
Mid-level Specialist
