Regulatory Affairs Associate, CMC & PMA Submissions

A pharmaceutical manufacturing company located in Miami, FL is seeking a Regulatory Affairs Associate to manage CMC dossiers and ensure compliance with FDA regulations for Class III implantable medical devices. The ideal candidate will have a BA/BS in Chemical or Biological Sciences and 4+ years of relevant experience. Responsibilities include preparing regulatory submissions, collaborating with project teams, and ensuring the accuracy and thoroughness of submissions.

This role is a contract position at the mid-senior level with strong project management and communication skills required.
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