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Manager, Regulatory Affairs Product Development

Application Deadline: June 2, 2020

Location: Schaumburg, IL, United States

Sagent Pharmaceuticals, Inc. seeks a Manager, Regulatory Affairs Product Development in our Schaumburg, IL office to serve as the primary regulatory interface with the U.S. Food and Drug Administration (FDA), Sagent’s third-party partners and its internal business units to ensure the technical quality and timely submission of new regulatory applications, amendments and/or supplements to support the company’s new product (pharmaceutical drug) development projects and in-licensing projects.

Requirements:

  • Master’s degree in Pharmacy (foreign equiv. acceptable); Bachelor’s degree in Pharmacy plus 5 years post-baccalaureate, progressive pharmaceutical drug regulatory compliance experience including preparing and filing eCTD format and Electronic ANDA submissions with the FDA

  • 3 years of pharmaceutical drug regulatory compliance experience including preparing and filing eCTD format and Electronic ANDA submissions with the FDA

  • Domestic travel up to 10% is also required


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