Regulatory Compliance Specialist

5 days ago


Leicester, Leicester, United Kingdom Aspire Pharma Limited Full time

About Aspire Pharma Limited

Aspire Pharma Limited is a rapidly growing UK pharmaceutical company that prioritizes improving patients' lives globally.

The business has developed a diversified portfolio of over 250 products across various categories, including branded specialty and unbranded niche generics. These products cater to underserved markets in areas such as urology, ophthalmology, CNS, and dermatology.

We are looking for a skilled Regulatory Compliance Specialist to join our team and contribute to the success of our company.

About the Role

This is an exciting opportunity to work with a talented team of professionals who share your passion for regulatory compliance in the pharmaceutical industry. As a Regulatory Compliance Specialist, you will be responsible for preparing and reviewing Product Quality Reviews (PQRs) and Technical Agreements. You will also monitor and ensure timely completion of reviews.

Your Key Responsibilities Will Include:

  • Technical Agreement Preparation and Review: Prepare new and existing Technical Agreements in line with internal standards.
  • PQR Request and Tracking: Request PQRs from Finished Product Manufacturers (FPMs), ensuring timely receipt and compliance with internal procedures.
  • APL PQR Preparation and Monthly Quality Checks: Prepare Annual Product Listings (APL) PQRs and perform monthly quality checks.
  • Vendor Performance Monitoring and Optimization: Support product launch activities by monitoring and optimizing vendor performance.
  • Effective Communication: Communicate effectively within the company and externally with vendors and customers.
  • Controlled Documentation Management: Update and manage controlled documentation, such as Standard Operating Procedures (SOPs) and Work Instructions.

About You

To succeed in this role, you should have a strong background in science, excellent attention to detail, and exceptional communication skills. Experience in MS Office applications is also essential. You should be able to manage time effectively and prioritize tasks.

Why Choose Us?

We offer a competitive salary, inclusive company culture, and opportunities for growth and development. Our benefits package includes:

  • Generous Pension Scheme.
  • Life Assurance cover and Employee Assistant Program.
  • 25 days holiday plus Bank Holidays.
  • Learning and Development opportunities.
  • Excellent opportunities for progression.
  • Fantastic Company events and celebrations throughout the year.

We look forward to welcoming a talented Regulatory Compliance Specialist to our team



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