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Entry Level Regulatory Specialist

Oak Lawn, IL
A global pharmaceutical company is looking to add a Regulatory Affairs Specialist to their dynamic team. This person requires a strong knowledge of FDA and ICH regulations. Working with this team will challenge individuals who are looking to get exposure in regulatory and compliance issues and develop submissions throughout the product lifecycle. 

Responsibilities: 
  • Maintain and obtain regulatory approvals 
  • Support labeling, advertising, and eCTD
  • Maintain existing approvals with timely reporting 
  • Develop and maintain regulatory expertise in support of product manufacturing 
  • Packaging component review 
Qualifications: 
  • B.S. in Scientific, Technical, or Healthcare field
  • 0 - 2 years pharmaceutical industry experience
  • Background in Quality Assurance and/or Research and Development is preferred 
  • Strong understanding of FDA regulations in the pharmaceutical industry
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