Associate Director, Labeling Expert

1 day ago


Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time
Job Title: Associate Director, Labeling Expert

Job Summary:

We are seeking an experienced Associate Director, Labeling Expert to join our Global Regulatory Affairs team. The successful candidate will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This role 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 Core Data Sheets/Label Changes, managing updates to Core Data Sheets for assigned products.
  • Conducts Label Review Committee Meetings, preparing documents for review by labeling teams.
  • Ensures compliance with labeling regulations and guidance, researching applicable Health Authority labeling regulations for products and filings.

Requirements:

  • 7+ years of pharmaceutical industry experience, with 4+ years of direct regulatory affairs experience, including US labeling experience.
  • Experience with ex-US labeling (outside the US) is preferred.
  • Ability to travel up to 10% occasionally.

About Daiichi Sankyo, Inc.:

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.



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