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Regulatory Affairs Specialist

Madison, WI
A global biopharmaceutical company is looking to add an experienced Regulatory Manager to their team. This role combines scientific regulatory and business issues to enable products that are developed, manufactured, and distributed meet required legislation. You will be serving as the liaison with the FDA. You will be working with people from several different departments including R&D, Quality Assurance, Project Managers, Operations and more. 

  • Ability to identify and collect data needed to prepare CMC regulatory product strategies under limited supervision
  • Prepare regulatory applications including new applications and amendments, renewals, annual reports and more 
  • Manage products and change control in compliance with regulations and company policies
  • Develops strategies for CMC meeting, manage preparation for agency meetings, and manage content for pre-meeting submissions
  • Train, develop, and mentor individuals 
  • B.S./M.S. in pharmacy, biology, chemistry, pharmacology, engineering, or related field
  • 3-5 years pharmaceutical industry experience working with the FDA, writing CAPAs, Auditing, etc. 
  • Experience working in complex environment
  • Experience leading a team of people 
  • Strong communication skills and ability to handle conflict
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