Regulatory Affairs Specialist

2 days ago


Oxford, Oxfordshire, United Kingdom Griffin Fire Full time
Regulatory Affairs Specialist

About the Role:
The Ellison Institute is seeking a skilled Regulatory Affairs Specialist to ensure our products and services meet regulatory requirements. As a key member of our team, you will develop and implement quality management systems, drive process improvement initiatives, and collaborate closely with our Clinic Manager and Laboratory Manager.

Key Responsibilities:
  • Develop and maintain a quality management system aligned with international standards.
  • Ensure regulatory compliance and collaborate with regulatory bodies as needed.
  • Conduct internal audits, oversee CAPA implementation, and prepare for external audits and inspections.
  • Lead initiatives to enhance quality, reduce waste, and improve operational efficiency.

Requirements:
  • Bachelor's degree in pharmaceutical or a science-related field.
  • Minimum of 5-7 years in a quality management role.
  • Qualified Person (QP) certification.
  • Proven expertise in pharmaceutical or biotechnology quality practices.

What We Offer:
A competitive salary range of £50,000 - £70,000 per annum, depending on experience, along with a generous bonus scheme, enhanced holiday pay, and a pension scheme.

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