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Regulatory Affairs Manager - Clinical Trials

Posted 1 day 9 hours ago by Cpl Healthcare

Permanent
Full Time
Government & Defence Jobs
London, United Kingdom
Job Description

Job Title: Regulatory Affairs Manager - Global Clinical Trials

Job Type: Full-time, Permanent Position

Location: White City, London, UK - Hybrid

Remuneration: £52,000 - £60,000

We are partnering with a growing not-for-profit medical research organisation focused on non-communicable diseases and injuries, with a global reach and major centers in Australia, China, India, and the UK.

This role will be supporting end-to-end CTA processes. As the only Regulatory Affairs professional based in the UK, you must be confident with global clinical trial regulations and have supported decentralised late-stage trials. The long-term goal of this role is having a team around this person.

Job Responsibilities include:

  • Manage a portfolio of CTAs, including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications, etc.
  • Provide support on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
  • Review and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
  • Ensure the approved company CTA processes are followed within agreed timelines.
  • Have a good understanding of CTR process and requirements.
  • Monitor key project milestones (actual vs. planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.
  • Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements are met, providing operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
  • Provide technical support on document preparation e.g. Excel spreadsheets, PowerPoint presentations.
  • Undertake all necessary training to achieve compliance with internal/external processes.
  • Provide operational support for the CTS Team as required.

Candidate Requirements include:

  • Eligibility to live and work in the United Kingdom
  • A Life Sciences degree or equivalent
  • Previous experience in clinical trials and ideally in the UK, ASIA, US, and Australia.
  • Excellent communication skills and ability to influence decisions

If this position is of interest to you, please forward your up-to-date CV to .

The role does not offer Sponsorship and needs the right candidates to hold full RTW in the UK.

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