Overview

Reference Number: JO-2112-481351
Regulatory CTA Consultant
Rate: Negotiable
Job Type: Contract
Location: Maidenhead

Regulatory CTA Consultant

12 month contract

Maidenhead- Flexible working offered

Inside IR35

Offering up to £26.00 Per Hour 

CPL Life Sciences have joined forces with a leading pharmaceutical company who are actively seeking a Regulatory CTA Consultant on a 12 month contract to support the preparation and submission of initial clinical trial applications (CTA) and CTA maintenance activities (substantial amendments, urgent safety measures, end of trial notifications etc.). The main priority will be to ensure the compliant regulatory maintenance of the assigned asset(s) across the UK.

The ideal profile will have a strong interest in Regulatory Affairs, preferably with 1-2 years experience working within the Regulatory sector.

Job Responsibilities include; 

– Manage a portfolio of CTAs across multiple and far-reaching therapeutic areas, 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 advice 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.

– Ensure approved company CTA processes are followed within agreed timelines.

– Work with the Global regulatory lead and other cross functional contacts responsible for development compounds with strategic and operational advice for clinical trials

– Provide advice on submission strategy 

– Liaise with key contacts in Regulatory Affairs, Clinical Study Management, Clinical Operations, Supply Chain and local affiliates to identify & resolve issues

– Ensure approved company CTA processes are followed within agreed timelines

Candidate Requirements 

– Must be eligible to live and work in the United Kingdom

– Life Sciences degree or equivalent 

– Previous Regulatory CTA submissions experience is advantageous

If this position is of interest please forward your up to date CV to Sophie on sophie.malyon@cpl.com