Regulatory Affairs Manager

1 week ago


Schaumburg, Illinois, United States Sagent Pharmaceuticals Full time
Manager, Regulatory Affairs – Product Development and Post Approval

Sagent Pharmaceuticals is a customer-focused pharmaceutical company delivering an extensive portfolio of injectable products.

We are seeking a Manager of Regulatory Affairs for Product Development and Post Approval to serve as the primary regulatory interface for Drug Product and Analytical method development, ensuring compliance with regulatory requirements.

Key Responsibilities:

Product Development:

  • Develop and implement regulatory strategies for new development projects
  • Prepare and submit regulatory documentation for FDA submissions
  • Communicate directly with FDA Reviewers to ensure compliance

Post Approval:

  • Compile and review Annual Reports and product labeling to ensure accuracy and compliance
  • Review proposed changes to manufacturing facilities and ensure regulatory compliance
  • Manage change controls according to regulatory guidelines to maintain compliance

Requirements:

Knowledge and Experience:

  • Strong knowledge of FDA regulations and guidelines
  • Experience in preparing submissions in CTD format
  • Ability to negotiate regulatory strategy with partners to ensure compliance

Minimum Qualifications:

  • 3-5 years of pharmaceutical development experience
  • Experience in preparing electronic ANDA submissions
  • Experience in a cGMP and/or FDA regulated environment

Education and Certifications:

BS/PharmD in Pharmacy, Biology, Chemistry, or Microbiology required



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