The Specialist will partner cross-functionally to ensure all labeling and artwork regulatory operational activities are planned, managed, and executed timely and accurately
Job Summary
The Specialist will partner cross-functionally to ensure all labeling and artwork regulatory operational activities are planned, managed, and executed timely and accurately.
Responsibilities include preparing high-quality labeling packages aligned with company requirements and supporting country regulatory affairs on database maintenance and records filings.
The role requires contributing to process improvements, collaborating with global labeling teams, and managing escalations across functional and divisional boundaries.
Matching Summary
The Specialist will partner cross-functionally to ensure all labeling and artwork regulatory operational activities are planned, managed, and executed timely and accurately.
Skills & Requirements
Must-have
2-3 years pharmaceutical industry experience
Labeling and artwork regulatory activities
Database maintenance and records filings
Cross-functional collaboration skills
Microsoft 365 proficiency
Nice-to-have
Design thinking and innovation mindset
Knowledge of local regional legislation
Operational excellence principles understanding
Experience with CMC changes impact
Process re-engineering capabilities
Key Requirements
Bachelor's degree in life science or related field
Minimum 2-3 years pharmaceutical industry experience