Regulatory Affairs Specialist – International Labeling Support

About the role

The Regulatory Affairs Specialist, International Labeling Support (ILS) partners with Global Regulatory Affairs and cross‑functional teams to ensure labeling and artwork activities are planned, managed and executed accurately and in compliance with regulations. The role also drives process improvements and supports metric preparation for business processes.

Key responsibilities

• Prepare high‑quality labeling and artwork packages and provide operational support to Country Regulatory Affairs.
• Maintain regulatory databases, record filings, and support metric preparation for designated processes.
• Collaborate with Global Labeling, Country/Regional Regulatory Affairs on labeling and artwork queries.
• Update process documentation, contribute to simplification and re‑engineering of processes.
• Coordinate cross‑functional projects impacting labeling/artwork, such as CMC changes and launch preparations.

Required profile

• Bachelor’s degree in life science, engineering, business or related field (pharmaceutical science preferred).
• 2–3 years of experience in the pharmaceutical industry, preferably in regulatory affairs, labeling, artwork, CMC or quality.
• Familiarity with local and regional pharmaceutical legislation and operational excellence principles.
• Ability to work in a matrixed, global environment and manage multiple projects simultaneously.

Required skills

• Proficiency with Microsoft 365 applications: Excel, PowerPoint, SharePoint.