Global Regulatory Affairs Labeling Expert

2 weeks ago


Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time
Job Summary

Daiichi Sankyo Group is a leading pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. We are seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team.

Key Responsibilities
  • Develop and maintain Company Core Data Sheets (CCDS) for assigned products, ensuring compliance with all applicable regulations and guidelines.
  • Manage updates to CCDS for assigned products, including US/EU and local country labeling deviations.
  • Prepare and implement regulatory documents, such as USPI, annotated labeling, medication guides, EU SmPC, PIL, and CCDS.
  • Lead cross-functional teams through all labeling discussions with the FDA/CHMP, ensuring management alignment and strategic planning for FDA meetings as needed.
  • Collaborate with Global Regulatory Leads (GRLs) and Clinical Safety Pharmacovigilance (CSPV) leads to ensure high-quality labeling documentation.
Requirements
  • Bachelor's Degree in a scientific discipline; advanced degree preferred.
  • 10+ years of pharmaceutical industry experience, with 4+ years of direct regulatory affairs experience, including CCDS and US/EU labeling experience.
  • Experience with country labeling a plus (outside the US/EU) preferred.
About Daiichi Sankyo, Inc.

Daiichi Sankyo Group is a global pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. With over 100 years of scientific expertise and a presence in over 20 countries, we are committed to delivering high-quality products and services to our customers and patients.



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