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Quality and Regulatory Affairs Manager

Quality and Regulatory Affairs Manager

Salary up to €60,000 DOE

Generous Annual Leave and Pension Plan

1 year contract with possibility to extend

My client, a well-regarded clinical research facility, is seeking a Quality and Regulatory Affairs Manager (QRAM) to join their team. In this role you will work closely with the clinical research team to maintain systems for quality assurance, ensure regulatory compliance across multiple clinical trials, and research and develop regulatory strategies. If you have minimum 5 years of experience as a QRAM or in a related role, then we would like to hear from you.

The Role

  • Maintain systems to ensure compliance of clinical trials/investigations, pharmacy services and clean room with regulatory requirements, ICH GCP guidelines and European legislation
  • Develop and implement regulatory strategies
  • Develop and lead an annual audit programme
  • Deliver training on ICH GCP and other regulatory guidelines to both internal and external personnel as required
  • Act as the lead for audit/inspection by relevant authorities including the HPRA; liaise with said authorities, accompany inspectors and provide timely responses to requests
  • Provide advice to internal and external stakeholders regarding best practice for the regulation and conduct of clinical research

Candidate Requirements

  • Minimum 5 years of experience in a QRAM or related role; a strong understanding of ICH GCP and other relevant regulations is required
  • Experience in an academic or commercial clinical research environment
  • Experience monitoring and/or auditing clinical trials
  • Proven organisational skills with excellent attention to detail
  • Strong communication skills (both written and verbal)

Salary & Benefits

  • Salary up to €60,000 DOE
  • 25 days annual leave
  • Pension plan
  • One year contract with possibility to extend
  • Opportunity to work with a dynamic team in a world-renowned research institution

How to Apply

If you are interested, please apply using the link below.

Please note that this role will be based on site in Dublin 8.

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[Quality and Regulatory Affairs Manager / #SW16096]

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