Regulatory Affairs Manager

We are partnering with a growing independent 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. This role will support all CTR transitions and initial submissions as well as studying studies globally. The right candidates will need previous regulatory EU CTR submission experience and experience in global clinical trials.

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 provide input on documents related to clinical trial submissions managed by other stakeholders such as IB and Protocols.
• Ensure the approved company CTA processes are followed within agreed timelines.
• Have a good understanding of CTR processes 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 and 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.
• Previous experience in clinical trials and ideally supported an EU CTR submission/transition.
• Excellent communication skills and the ability to influence decisions.

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

The role does not offer sponsorship and requires candidates to hold the full right to work in the UK.