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Expired
  • Salary: Competitive Salary plus Benefits
  • Job Type:Permanent

Posted over 2 years ago

  • Contact: Adrienn Prezenszki
  • Contact Email: adrienn.prezenszki@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-08-31
  • Job Ref: V-46993
A pioneering company who are at the center of the Cell & Gene Therapy sector are seeking a Clinical & Regulatory Affairs Administrator to support the Regulatory Affairs and Clinical Operations Team based in Central London.  
 
The Role
The position is mainly focused on Regulatory activities with involvement in Clinical Operations work.
 
Key Responsibilities:
  • Collate, coordinate and Quality Control document packages for submission to regulatory agencies, ethics committees and bodies responsible for compliance with ATMP and device regulations
  • Produce regulatory/ ethics dossiers and complete submission to regulatory agencies
  • Maintaining TMF correctly and all required documents are present and when required, verified
  • General administrative support such as arranging meetings, minuting as appropriate, formatting/ publishing and administer QC checks on regulatory/ clinical documents, general filing, raising shopping carts
  • QA and QMS related activities including team compliance, regulations and guidelines and company processes, updating SOP’s and raising CAPA’s
  • Utilise and develop systems to track status of key clinical and regulatory documents, including the TMF documentation, as well as PO’s, invoices and contracts
  • Ensuring non – compliance and other issues are detected promptly and reported, resolved, and escalated as required in compliance with project plans and SOP’s
  • Supporting trial vendor management including establishment of contracts and monitoring vendor compliance
  • Being the point of contact for clinical sites for essential trial documents
  • Supporting submission process for key clinical documents with regulatory team
  • Working with the Quality Department to support clinical audits, both internal and external, supporting the provision accurate and complete audit reports
  • Support the development of processes for ATMP logistics for clinical trials
  • Team SharePoint management
  • Establish strong constructive relationships with other departments as well as with external collaborators and partners
 
Experience and Skills
A Life Science degree in Biological Science Pharmacy or other health related discipline would be preferred or equivalent nursing qualification/experience. You will ideally have experience in compiling of regulatory documentation and familiar with UK regulatory environment and NHS operational requirements. You will also have experience with detail of ICH, GCP guidelines and working with or in the NHS clinical trial structure in the UK. You must have around 2 years or more experience related to clinical trials including production and review of study documents and TMF maintenance. Knowledge of UK Human Tissue Act legislation would be advantageous.
 
You will need to be flexible towards work assignments, new learning, and travel as overnight stays may be required. You will have strong attention to detail and excellent organizational skills, as well as good interpersonal and communication skills including being able to explain information and teach others. You need to be able to manage varied tasks and prioritize workload. You must enjoy working in a regulatory environment, keeping up to date with regulations, scientific advances, expertise, and best practices.
 
Company Overview
The company was established in 2012 with the purpose to make the UK the place to commercialise Cell & Gene Therapies working in collaboration with partner based in the UK, Europe, US and Asia for example. The offer cutting edge technology, services, and capabilities to take a therapy across the translational gap. Then into the clinic, through clinical trials to launch. They have now expanded to 3 sites with a unique GMP manufacturing site for AMTP’s / Cell & Gene Therapies based in Stevenage. With a linked cluster that offer the capability to manufacture these life changing therapies for clinical trial and at a commercial scale.