Regulatory Project Specialist

Job Ref: J24545
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 29 November 2017
  • North Lanarkshire, Scotland, UK
  • Competitive
  • Natasha Rollason

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The Role:

Provide comprehensive support to the Regulatory Affairs and Clinical Operations teams to coordinate the logistical and regulatory aspects of the clinical trials in compliance with ICH GCP/company SOPs.

Key Responsibilities:

  • Involved in clinical trial activities - specifically preparation for study site set up, conduct and close out of a clinical trial and provide administrative support to the Clinical Team specifically with regard to collating trial master files, implementing and maintaining spreadsheets and databases for tracking patients and clinic visits.
  • Assist with the Ethics/Regulatory Submissions; keeping a track of submissions & approvals for the study, using IRAS and CESP.
  • Maintain information on worldwide regulatory requirements and the status of product registrations and Liaise with all departments and project teams to co-ordinate timely applications for regulatory approvals.
  • Setting-up and maintaining Trial Master Files, Investigator Site Files and QMS documents and folders according to current SOPs and indexes.
  • Assist in the tracking and distribution of safety reports and safety information to investigator sites according to SOPs and prevailing law.
  • Work with Finance to implement and maintain systems scheduling payments to clinical trial sites and regulatory authorities in a timely manner.
  • Work with the CRA, VP Clinical and HC&R for the production of clinical study materials and the GMP Production Manager and Clinical Research Associate to ensure both production and treatment schedules are fully aligned.
  • Maintain filing/retrieval systems and the uploading and downloading of documentation to dedicated company files. Arrange transfer of documents from the Trial Master File to the ISF.
  • Ensure quality management systems are fully integrated between Clinical and GMP Operations e.g. would include integration of vendor review/approval and maintenance and supply agreements, CTA Agreements, CRO Agreements and SOPs.

Skills:

  • Experience in life sciences sector or educated in life sciences field
  • Experience in Regulatory application process, dossier preparation using Integrated research Application System and Central European Submission Platform.
  • Experience of Quality Management Systems and knowledge of ICH GCP, GM

If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.