International Labeling Support Specialist

About the role

The International Labeling Support Specialist partners with Global Regulatory Affairs, Country Regulatory Affairs and cross‑functional teams to ensure labeling and artwork activities are planned, managed and executed accurately and in compliance with regulatory requirements.

Key responsibilities

• Prepare high‑quality labeling and artwork packages and provide operational support for regulatory activities, including database maintenance and record filings.
• Support metric preparation, process documentation updates and continuous improvement initiatives for labeling and artwork processes.
• Coordinate follow‑ups and escalations across functions after key milestones such as HA submissions and approvals.
• Collect country‑specific inputs, plan execution, and support cross‑functional projects impacting labeling, CMC changes and launch artwork preparation.

Required profile

• Bachelor’s degree in life science, engineering, business or related field; Master’s degree preferred.
• 2–3 years of experience in the pharmaceutical industry, preferably in Regulatory Affairs, labeling/artwork, CMC or quality compliance.
• Familiarity with local and regional pharmaceutical legislation and operational excellence principles.
• Strong organizational, communication and matrix‑working skills in a culturally diverse environment.

Required skills

• Microsoft Excel
• Microsoft PowerPoint
• Microsoft SharePoint
• Electronic Common Technical Document (eCTD) preparation