Regulatory Affairs Specialist - International Labeling Support (ils)

medhunter.de

Hybrid
International labeling support
Regulatory affairs operational activities
Labeling and artwork preparation
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 a hybrid working model, opportunities for professional growth, and a competitive salary with incentive pay.

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 Affairs operational activities
  • Labeling and Artwork preparation
  • Process improvement identification
  • Cross-functional collaboration
  • Database maintenance and record filings

Nice-to-have

  • Innovative mindset and design thinking
  • Interest in new tools or automatization
  • Familiarity with local/regional legislation
  • Understanding of Operational Excellence principles
  • Ability to work in a matrix approach

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 (labeling & artwork, CMC, compliance, quality)
  • Proficiency in Microsoft 365 apps (Excel, Power point, SharePoint)

Work Rights

Not specified

Tailored Resume

Cover Letter