Senior Associate, Regulatory Submissions - 100% Home-Based in the UK Maidenhead, England
Job description
As a leading contract research organization (CRO), Fotrea (formerly known as Labcorp & Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Fortrea Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Role Details:
Responsible for providing support to a UK Client, ensuring the timely Regulatory submissions of new initial Clinical Trial of Investigational Medicinal Products (CTiMP) applications and Amendments via the stipulated electronic application systems (currently Combined Review in the UK).
Must have full intricate knowledge in order to provide valuable expertise and guidance in formulating full CTA document packages and essential information to the Regulatory Authorities, specifically MHRA in UK & HPRA in the ROI (CTIS not essential), for a range of disease indications and drug/placebo based Clinical Trials.
Liaises with the applicable Regulatory Authorities and with clients to support and advise on all regulatory activities regarding new Clinical Trial applications and Amendments. Proactively interacts as part of a small startup team, comprising of other Ethics and Regulatory experts and also with other internal Fortrea groups and directly with external client Clinical Operation Managers.
Overall provide guidance on all Regulatory Authority requirements with the main goal of meeting project timelines and Client KPI’s.
It is the responsibility of the Regulatory Associate to be 100% confident in preparing documentation packages and forms from scratch, utilising only essential documents provided by the Client.
No template forms will be provided and so it is essential for the candidate to have the right level of knowledge and expertise in order to scrutinise and assess document packages; understand the requirements to identify any missing documentation from the client; prepare packages to the high standard of quality and expectations and finally to support a thorough QC process prior to submission. The Regulatory Associate will be expected to follow through applications from initial request to approvals and beyond, processing any additional requirements via amendments & appropriate scheduled reporting, until final Trial close out.
The Regulatory Associate is also expected to lead mentoring and provide guidance to other colleagues within the team. Training will be provided where necessary, on the Ethical application process and requirements of Clinical Trial as a further development opportunity.
This role is 100% home based, anywhere in the UK.
Essential Job Duties:
Critically assess, scrutinize and prepare all required core study documentation packages and application forms for submission of new initial CTiMP trials and Amendments in the UK.
Support production of ROI application documentation as necessary for Client submissions via EUCTR process.
In depth, overall expertise and knowledge of the UK Combined Review application system and in particular full completion from scratch of the Medicine’s Information Form, will be essential.
Experience of formulating other documentation independently e.g cover letters, Amendment Tools, etc. is also essential, although templates and training to Client requirements will be provided.
Support the preparation of other routine submissions filed to Regulatory Authorities (e.g. DSURs, APRs, EOT notifications). Will take ownership for specific pieces of work and will be the Regulatory Submissions lead for projects.
Review/summarize scientific/research documents in preparation for submission to Regulatory Authorities.
Coordination, collection and organisation of data and information required by Regulatory Authorities.
Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to Regulatory Authority submissions.
Expectation to support training of other colleagues in the Regulatory Clinical Trial Submissions Space. Lead and support QC processes of other colleague’s submissions
Will participate independently in client meetings and will proactively liaise with clients’ Clinical Operations Managers on regulatory submission requirements and issues.
May take overall Submissions lead role (Ethics and Regulatory applications) for Clinical Trials, with mentoring.
Train, mentor and coach other Start-up colleague team members.
Work on special regulatory projects as assigned, keep up to date with current legislation to disseminate to others as required.
Education, Skills and Other Requirements:
Minimum of 3-4 years of experience in the Pharmaceutical industry specifically in making Competent Authority Clinical Trials Applications and amendments within the UK.
Extensive experience and knowledge in Regulatory Submissions (importantly building up EudraCT forms and Medicine’s Information forms from scratch utilising core documentation only, rather than being provided with already formulated template from Client.)
Strong communication skills and motivation to support less experienced team-members
Ability to work in a global and multi-cultural team setting
Did you know?
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.
Labcorp is proud to be an Equal Opportunity Employer:
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