Associate Director, Global Regulatory Affairs Labeling Expert

5 days ago

Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time
About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving the lives of patients worldwide. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to delivering high-quality products that meet the evolving needs of healthcare professionals and patients.

Job Summary

We are seeking an experienced Associate Director to join our Global Regulatory Affairs team as a Global Regulatory Labeling Lead. In this role, you will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). You will manage multiple assigned projects of increased complexity, including post-marketing projects and those involving 3rd party development.

Key Responsibilities
  • Acts as point of contact for cross-functional teams on global labeling issues.
  • Prepares and implements regulatory documents, including USPI, annotated labeling, medication guides, EU SmPC, PIL, and CCDS.
  • Ensures compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format.
  • Manages updates to Core Data Sheets for assigned products and ensures implementation of CCDS/labeling agreements with licensing partners.
  • Leads review processes and ensures appropriate governance for US, EU, and Company Core documents as well as for the review of country labeling deviations.
Requirements
  • Bachelor's Degree in a scientific discipline required; advanced degree (e.g., Master's, Pharm.D., or Ph.D.) preferred.
  • 7 or more years of pharmaceutical industry experience required; 4 or more years of direct regulatory affairs experience, including US labeling experience required.
  • Experience with ex-US labeling (outside the US) preferred.
  • Ability to travel up to 10%.
About the Role

This is an exceptional opportunity to join a dynamic team and contribute to the development of innovative products that improve patient outcomes. As a Global Regulatory Labeling Lead, you will have the opportunity to work with cross-functional teams, develop your leadership skills, and make a meaningful impact on the company's success.

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