Regulatory Affairs Specialist - International Labeling Support (ils)
Merck Sharp & Dohme LLC
Rahway, New Jersey, USA
Hybrid
International labeling support
Regulatory operational activities
Labeling and artworks
The role partners cross-functionally and cross-divisionally to ensure labeling and artwork regulatory operational activities are planned, managed, and executed timely, accurately, and compliantly
Job Summary
The role partners cross-functionally and cross-divisionally to ensure labeling and artwork regulatory operational activities are planned, managed, and executed timely, accurately, and compliantly.
Specific responsibilities include preparing high-quality labeling and artwork packages, providing operational support to Country Regulatory Affairs, and collaborating on labeling & artworks queries.
The company offers an international environment, opportunities for professional growth, a hybrid working model, and a comprehensive benefits package including pension, health insurance, and generous leave allowances.
Matching Summary
The role partners cross-functionally and cross-divisionally to ensure labeling and artwork regulatory operational activities are planned, managed, and executed timely, accurately, and compliantly.
Skills & Requirements
Must-have
International Labeling Support
Regulatory operational activities
Labeling and Artworks
Process improvement identification
Database maintenance
Records filings
Nice-to-have
Innovative mindset
Design thinking skills
Culturally diverse environment
Interest in new tools
Key Requirements
Bachelor's degree in life science, engineering, business or related field
2–3 years’ experience in pharmaceutical industry
Experience in Regulatory Affairs
Familiar with local and regional legislation frameworks