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.
1. 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.
2. Providing support on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
3. Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
4. Ensuring the approved company CTA processes are followed within agreed timelines.
5. Good understa...