Regulatory Affairs Associate

4 days ago


Leicester, Leicester, United Kingdom Aspire Pharma Ltd Full time
Key Responsibilities:
  • Technical Agreements Preparation: Prepare and review new and existing Technical Agreements in accordance with internal standards.
  • PQRs Management: Request and track Product Quality Reviews (PQRs) from Finished Product Manufacturers (FPMs), ensuring timely receipt and compliance with internal procedures.
  • APL PQRs and Quality Checks: Prepare Annual Product Listings (APL) PQRs and perform monthly quality checks.
  • Vendor Performance Monitoring: Support product launch activities, ensuring vendor performance is monitored and optimized.


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