Regulatory Affairs Specialist - International Labeling Support (ils)
Merck & Co., Inc., Rahway, NJ, USA
Hybrid
International labeling support
Regulatory operational activities
Labeling and artworks
The role will partner cross-functionally to ensure all Labeling and Artworks regulatory operational activities are planned, managed, and executed timely, accurately and in a compliant way
Job Summary
The role will partner cross-functionally to ensure all Labeling and Artworks regulatory operational activities are planned, managed, and executed timely, accurately and in a compliant way.
Specific responsibilities include preparing high quality labeling and artwork packages, providing operational support to Country Regulatory Affairs, and collaborating with Global Labeling for queries.
The company offers an exciting work environment in a global, international setting with opportunities for professional growth, a hybrid working model, and comprehensive benefits.
Matching Summary
The role will partner cross-functionally to ensure all Labeling and Artworks regulatory operational activities are planned, managed, and executed timely, accurately and in a compliant way.
Skills & Requirements
Must-have
International Labeling Support
Regulatory operational activities
labeling and artworks
process improvement implementation
database maintenance
records filings
Nice-to-have
culturally diverse environment
innovative mindset
design thinking skills
interest in new tools
Operational Excellence principles
Key Requirements
Bachelor’s degree in life science, engineering, business
Minimum 2–3 years’ experience in pharmaceutical industry
Previous experience in Regulatory Affairs
familiar with local and regional legislation frameworks