Regulatory Affairs Specialist

6 days ago


Leicester, Leicester, United Kingdom Aspire Pharma Limited Full time
Job Title

A Regulatory Affairs Specialist is required to maintain and comply with approved products in the pharmaceutical industry.

The ideal candidate will work closely with various departments to compile, publish, and submit new product dossiers and technical files as required by the business.

Maintaining an awareness of current regulatory and GxP requirements is essential to advise on opportunities and threats to product licenses, development, and regulatory strategies.

Key Responsibilities:
  • Submission, maintenance, and control of regulatory information and documentation for medicines, medical devices, and other products.
  • Acting as a first point of contact for third parties, regulatory agencies, and internal departments for specific issues relating to products.
  • Coordinating with internal and external stakeholders to prepare responses to requests for information from regulatory authorities within stated timelines.
  • Assisting with regulatory due diligence of new products using knowledge of current regulations and guidance.
  • Proactively liaising with internal and external stakeholders regarding issues relating to projects.
  • Maintaining awareness of new and existing legislation and guidance from regulatory competent authorities.
Requirements:
  • Degree in a scientific or similar discipline.
  • Proficient in Microsoft Office packages such as Word, Outlook, PowerPoint, Excel, and also having the ability to learn other in-house programs (SharePoint).
  • Scientific writing.
What We Offer:

We offer a competitive salary and company benefits package including:

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

Salary: £43,500 per annum.



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