Associate Director, Global Regulatory Affairs Labeling

1 month ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Job Summary

This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects.

Key Responsibilities
  • Acts as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.
  • Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for assigned products. Manages US/EU and local country labeling deviations from CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.
  • Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams. Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
  • Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format.
  • Establishes Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements.
Requirements
  • Bachelor's Degree preferably in a scientific discipline required
  • Advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred
  • 7 or More Years pharmaceutical industry experience required
  • 4 or More Years of direct regulatory affairs experience, including US labeling experience required


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