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.

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
A Life Sciences degree or equivalent
Previous experience in clinical trials and ideally in the UK, ASIA, US and Austrilia.
Excellent communication skills and ability to influence decisions

If this position is of interest to you, please forward your up-to-date CV to [email protected]

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