Regulatory Affairs Consultant

Job Title: Regulatory Affairs Coordinator CTA/CTR (Consultant)

Job Type: 12 Month Contract

Location: Berkshire, UK – 2 days on site per week

Rate: Up to £55 per hour PAYE (inside IR35)

We are partnered with a leading Pharmaceutical organisation who are looking for a Regulatory Consultant to join on a 12-month contract basis. This role will be sat in the core regulatory CTA team and will be supporting end-to-end CTA processes. This role will support all CTR transitions and initial submissions as well as studying studies globally.

This role will require the right candidates to have previous regulatory EU CTR submission experience and want to become an SME in EU CTR. This role will also support with the uploading on CTR submissions onto the new CTIS portal.

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 supported an EU CTR submission/transition
• Excellent communication skills and be able to influence decisions

Please note this position falls inside IR35 and has no opportunities to go through LTD, 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 be on-site 2x a week in Berkshire, UK.