Associate Director, Global Regulatory Affairs Labeling

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Wilmington, United States EPM Scientific Full time

Associate Director, Global Regulatory Affairs Labeling


Company Summary:

My client, a growing global biopharmaceutical company, is focused on the discovery and development of treatments for unmet needs in oncology and dermatology. They are looking to add a Global Regulatory Affairs Labeling Associate Director to their team on a hybrid basis to their site in Wilmington, DE


The Global Regulatory Affairs Labeling Associate Director will be responsible for:

  • Creating, updating and maintaining labeling documents throughout the product lifecycle.
  • Leading cross-functional teams in development, revision, review and approval of Company Core Data Sheet and product labeling documents for assigned products.
  • Providing labeling expertise/guidance to teams about labeling content, processes and timelines.
  • Serving as the point of contact on Global Regulatory sub-teams to ensure delivery of labeling documents meet quality, compliance and regulatory standards.


The Global Regulatory Affairs Labeling Associate Director should have the following qualifications:

  • Bachelor’s degree and 4+ years of direct regulatory labeling experience in the pharmaceutical industry.
  • US regulatory labeling experience is required.
  • Ex-US regulatory labeling experience is a plus.
  • Ability to guide cross-functional teams and drive consensus on labeling issues.



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