The Specialist will partner cross-functionally to ensure all labeling and artwork regulatory activities are executed timely, accurately, and in compliance
Job Summary
The Specialist will partner cross-functionally to ensure all labeling and artwork regulatory activities are executed timely, accurately, and in compliance.
Responsibilities include preparing high-quality labeling packages, maintaining databases, and supporting country regulatory affairs with necessary filings.
The role requires contributing to process improvements and utilizing design thinking to simplify tools and workflows within the pharmaceutical sector.
Matching Summary
The Specialist will partner cross-functionally to ensure all labeling and artwork regulatory activities are executed timely, accurately, and in compliance.
Skills & Requirements
Must-have
2-3 years pharmaceutical industry experience
Regulatory affairs and labeling expertise
Microsoft 365 proficiency including Excel
Nice-to-have
Design thinking and innovative mindset
Process re-engineering capabilities
Cross-functional matrix collaboration skills
Key Requirements
Bachelor's degree in life science or related field
Minimum 2-3 years experience in pharmaceutical industry
Experience with CMC changes and artwork preparation