Regulatory Affairs Expert with Biologic CMC Experience

5 days ago


King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

Parexel International Corporation is seeking a seasoned Regulatory Affairs Associate to support the CMC activities related to vaccine and biologic manufacturing and control.

Key Responsibilities:

  • Author submission dossiers for new applications, post-approval variations, and understanding of EU/CA/WHO/US regulations & guidance.
  • Compile data to appropriate standards & requirements.
  • Experience in CTD update/authoring (CTD Module 1, 2&3).
  • Handle and respond to Health Authorities Requests.
  • Support US & CA Annual reports, Renewals, PQVAR, APR.

Requirements:

  • Bachelor's or Master's degree in Pharmacy or Life Sciences.
  • 5+ years of experience in Biologic CMC.

Preferred Qualifications:

  • Veeva tool experience.

Estimated Salary: $120,000 - $180,000 per year.



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