Regulatory Affairs Manager - Global Clinical Trials

JR United Kingdom; London; Hybrid; GBP 40,000 - 80,000; Full time

Job description

Regulatory Affairs Manager - Global Clinical Trials, London

Client:

Cpl Life Sciences

Location:

London, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

7

Posted:

18.04.2025

Expiry Date:

02.06.2025

Job Description:

Regulatory Affairs Manager - Global Clinical Trials

Job Type: Full-time, Permanent Position

Location: White City, London, UK – Hybrid

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:

• Managed 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.
• Providing support on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
• Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
• Ensuring the approved company CTA processes are followed within agreed timelines.
• Good understanding of CTR process and requirements.
• Monitored 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.
• Responsible for all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
• Providing technical support on document preparation e.g. Excel spreadsheets, PowerPoint presentations.
• Undertaking all necessary training to achieve compliance with internal/external processes.
• Providing operational support for the CTS Team as required.

Candidate Requirements include:

• Eligibility to live and work in the United Kingdom
• 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 [e-mail]

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

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.