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Regulatory Affairs Manager

2 months ago

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

Sagent Pharmaceuticals

Sagent Pharmaceuticals is dedicated to providing a comprehensive range of injectable products tailored to meet customer needs. We are in search of a Regulatory Affairs Manager specializing in Product Development and Post-Market Compliance. The successful candidate will act as the main regulatory liaison for Drug Product and Analytical method advancement, ensuring adherence to regulatory standards.

Core Responsibilities:

Product Development

  • Offer regulatory insights and strategies for innovative development initiatives
  • Draft regulatory documentation for submissions to the FDA
  • Engage directly with FDA reviewers to facilitate communication

Post-Market Compliance

  • Compile and assess Annual Reports and product labeling
  • Evaluate proposed modifications to manufacturing processes
  • Oversee change controls in accordance with regulatory protocols

Required Knowledge and Experience:

  • In-depth understanding of FDA regulations and guidelines
  • Proficient in preparing submissions in CTD format
  • Capability to negotiate regulatory strategies with stakeholders

Minimum Qualifications:

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

Educational Background:

A degree in Pharmacy, Biology, Chemistry, or Microbiology is required.

Sagent Pharmaceuticals is an equal opportunity employer and does not discriminate based on race, color, religion, sex, age, national origin, veteran status, or disability.