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Regulatory Affairs Labeling Manager

4 weeks ago

Atlanta, Georgia, United States Proclinical Staffing Full time
Job Title: Manager, Regulatory Affairs Labeling

Proclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company.

Key Responsibilities:

  • Lead the development of new labeling content in collaboration with a cross-functional project team.
  • Manage the creation and maintenance of all US product labeling components using established labeling and artwork procedures.
  • Compile labeling documents for all submissions, including labeling information and drug listing for products manufactured by the company for distribution within the US.
  • Manage the compilation of labeling documents for all FDA submissions, including managing artwork revisions.
  • Coordinate artwork revisions and FDA submissions.
  • Maintain drug product listings and establishment registrations, and generate SPL for labeling submissions.

Requirements:

  • Bachelor's degree or higher.
  • At least 5 years of relevant experience in the pharmaceutical industry, with preferably 3 years in Regulatory Affairs and specific experience in US Labeling.
  • Knowledge of US labeling regulations and guidance.
  • Knowledge of science and data of assigned products and how that translates into labeling language.
  • Product launch experience preferred.

About Proclinical:

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.