Regulatory Affairs Manager - Clinical Trials

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 lucy.kirkaldy@cpl.com.

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