Regulatory Associate - CTA/ CTIS FOCUS 12 month contract

  • Hays Specialist Recruitment Limited
  • Iver, Buckinghamshire
  • Feb 01, 2024
Full time Engineering

Job Description

Your new companyAn innovative and global biotechnology company is looking to bring 2 Regulatory Affairs Clinical Trial Associates into the team until the end of 2024. They have a really exciting pipeline for those really driven by science.

Your new roleIt is a vital role to ensure technical compliance of the clinical trial submissions via flow of information to all functional areas, ensuring compliance with EU CTR for every single clinical trial submission dossier. You will be coordinating the clinical trial submissions and notifications in the document management system and maintaining the tracking. You will be responsible for reviewing and triaging requestions for information from health authorities through CTIS to relevant teams. In addition, you will be assisting with the definition, development, and implementation of processes to meet the CTIS needs. Raising, resolving any issues that may impact the submission process or timelines within the CTIS.

What you'll need to succeedMust have at least 6 months experience working with CTIS in a regulatory function. You must have the right to work in the UK, and be located in the UK.

What you'll get in returnHybrid/ almost remote working-travel to site is at a maximum of once per month, so flexible on location in the UK. Good rate on offer, and a 12-month contract working for an innovative biotechnology company.

What you need to do nowIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV and reach out to Julia Bowden at Hays.