Job Summary

A clinical research organization has a current position open for a Telecommute Regulatory Labeling Manager.

Must be able to:

• Provide labeling operations support to the Global Regulatory Affairs portfolio
• Formulate strategies for the submission and implementation of new and revised prescribing information
• Build and maintain strong collaborative relationships with key internal and external stakeholders

Required Skills:

• Bachelor’s degree in relevant field of study
• 8 years of relevant experience
• OR equivalent combination of education, training, and relevant experience
• US/EU/ROW experience
• Knowledge of the scientific principles of the drug development process
• Advanced, broad knowledge of regulations pertaining to drug product labeling