Regulatory Affairs Specialist - International Labeling Support (ils)
Merck Sharp & Dohme LLC
Hybrid
International labeling support
Regulatory affairs operational activities
Labeling and artworks
The role partners cross-functionally and cross-divisionally to ensure regulatory operational activities for labeling and artworks are planned, managed, and executed timely, accurately, and compliantly
Job Summary
The role partners cross-functionally and cross-divisionally to ensure regulatory operational activities for labeling and artworks 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 with various teams for queries and process documentation updates.
The company offers an exciting work environment, global projects, international exposure, opportunities for professional growth, and a hybrid working model.
Matching Summary
The role partners cross-functionally and cross-divisionally to ensure regulatory operational activities for labeling and artworks are planned, managed, and executed timely, accurately, and compliantly.
Skills & Requirements
Must-have
International Labeling Support
Regulatory Affairs operational activities
Labeling and Artworks
Process improvement identification
Database maintenance and record filings
Cross-functional collaboration
Nice-to-have
Innovative mindset and design thinking
Interest in new tools or automatization
Operational Excellence principles
Culturally diverse environment
Key Requirements
Bachelor's degree in life science, engineering, business or related field
Minimum 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