Regulatory Affairs Specialist - International Labeling Support (ils)
Merck & Co., Inc., Rahway, NJ, USA
Hybrid
International labeling support
Labeling and artwork operations
Regulatory operational activities
Partner cross-functionally to ensure labeling and artwork regulatory operational activities are planned, managed, and executed timely, accurately, and compliantly
Job Summary
Partner cross-functionally to ensure labeling and artwork regulatory operational activities are planned, managed, and executed timely, accurately, and compliantly.
Prepare high-quality labeling and artwork packages, provide operational support to Country Regulatory Affairs, and collaborate on labeling & artworks queries.
Contribute to process improvement, support necessary follow-ups and escalations, and partner with Country Regulatory Affairs for accurate planning and execution.
Matching Summary
Partner cross-functionally to ensure labeling and artwork regulatory operational activities are planned, managed, and executed timely, accurately, and compliantly.
Skills & Requirements
Must-have
International Labeling Support
Labeling and Artwork Operations
Regulatory Operational Activities
Process Improvement Implementation
Cross-functional Collaboration
Microsoft 365 Apps Proficiency
Nice-to-have
Innovative Mindset
Design Thinking Skills
Culturally Diverse Environment
Interest in New Tools
Operational Excellence Principles
Key Requirements
Bachelor's degree in life science, engineering, business or related field
2–3 years' experience in pharmaceutical industry
Previous experience in Regulatory Affairs (labelling & artwork), CMC, compliance management or quality
Familiarity with local and regional legislation frameworks