Global Regulatory Affairs Labeling Expert

2 days ago


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

Daiichi Sankyo, Inc. is seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs).

Responsibilities
  • Act as point of contact for cross-functional teams on global labeling issues.
  • Manage updates to Core Data Sheets for assigned products.
  • Manage US/EU and local country labeling deviations from CCDS.
  • Prepare documents for review by labeling teams.
  • Lead review processes and ensure appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
  • Research applicable Health Authority labeling regulations for products and filings.
  • Manage compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format.

Requirements
  • 10 or more years of pharmaceutical industry experience required.
  • 4 or more years of direct regulatory affairs experience, including CCDS and US/EU labeling experience required.
  • Experience with country labeling a plus (outside the US/EU) preferred.

What We Offer

Daiichi Sankyo, Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.

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