Regulatory Affairs Leader for Gene Therapies

2 days ago


Cambridge, Cambridgeshire, United Kingdom Pure Resourcing Solutions Full time

Pure Resourcing Solutions

Estimated Salary: £60,000 - £80,000 per annum

About the Role:

We are seeking an experienced Regulatory Affairs professional to lead our Gene Therapy Compliance team. This is a unique opportunity to develop and implement process development compliance for gene therapies.

Key Responsibilities:

  • Ensure Quality Management System (QMS) compliance in accordance with relevant regulations and industry standards.
  • Investigate and resolve non-conformities, including conducting root cause analysis and implementing corrective actions.
  • Lead Site Management Review meetings to ensure compliance with regulatory requirements.
  • Develop and maintain quality reports to track performance and identify areas for improvement.
  • Collaborate with cross-functional teams to ensure seamless integration of QA activities into product development and manufacturing processes.

Requirements:

  • Degree in Life Sciences or a related field.
  • Significant experience in cell and/or gene therapy product manufacture, preferably in a leadership role.
  • Thorough understanding of Good Manufacturing Practice (GMP) and Advanced Therapy Medicinal Products (ATMPs).
  • Able to lead and deputise for senior management.


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