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Regulatory Affairs Specialist

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Madison, WI
Job Type
Direct Hire
Feb 07, 2018
Job ID
Our client is a producer of Bio-pharmaceuticals. They have developed core competencies in the development of processes and products derived from natural sources both animal-based and plant-based. They have an immediate opening for a Regulatory Affairs Specialist.

  1. This position will provide regulatory support for development and commercial programs.
  2. In this role, you will plan, coordinate and oversee regulatory activities.
  3. These activities include the preparation of document packages for regulatory submissions, and timely preparation of well-organized and technically accurate submissions to the US FDA and other global agencies. 
  4. You will also be responsible for preparing and maintaining internal procedures, such as Standard Operating Procedures (SOP), and ensuring regulation compliance.
  • B.S. in Chemistry or Chemical Engineering plus at least 2+ years of experience in cGMP finished dosage form Chemical Manufacturing Control (CMC) is required.
  • Personal experience investigating and submitting NDAs, DMFs, and CTAs is highly preferred.