Job Summary
Key responsibilities
·Leads cross-functional teams in the development, revision, review, and approval of Company Core Data Sheet and regional/local product labeling documents, for assigned products, in line with regulatory and internal standards and guidelines.
·Provides labeling expertise and guidance to teams about labeling content, processes, and timelines.
·In collaboration with Supply Chain, contributes to the development of new and updated packaging mock-ups and artwork for submission purposes.
·Serves as the point of contact on Global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality, compliance, and regulatory labeling standards, to support timely regulatory submissions for assigned products.
·Ensures high quality and compliant labeling documents.
·Contributes to the continuous improvement of the end-to-end labeling process.
·Supports internal and external audits/inspections as a labeling subject matter expert.
Qualifications
·Bachelor’s degree in a scientific discipline. Advanced degree preferred (MS, PharmD, PhD).
·Relevant experience in the pharmaceutical industry including 4+ years of direct regulatory labeling experience.
·US labeling experience required; ex-US labeling experience preferred.
·Ability to guide cross-functional teams (including senior management) and drive consensus to address labeling issues.
·Self-starter with an ability to assimilate clinical and scientific information and present it concisely. Understanding of medical concepts and terminology.
·Strong project management skills with the ability to handle multiple projects and prioritize work accordingly.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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