Regulatory Start-Up Specialist (fixed-term)

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.



Fortrea is currently seeking a proactive Clinical Trial Regulatory Start-Up Specialist to join our client-dedicated Team. The Regulatory Specialist will support Clinical Operation Managers and a Team of Start-Up Specialists in the preparation and submission of key documentation to the Competent Regulatory Authorities for new Clinical Trials of Investigational Medicinal Products in the UK, (supporting ROI also, only when necessary), and subsequent amendments as part of Trial maintenance. This role will involve confident completion of the Medicines Information Form, with a specific focus on Section D9 within the IRAS/Combined Review process.



Alongside a specialism of submissions to the Competent Authorities, the ideal Candidate will also have experience in Combined Review submissions to the Ethics/HRA and ARSAC.



Regulatory Submissions Specialists are Client facing, working with client Clinical Operation Managers in order to perform submissions. They provide all professional support and regulatory guidance to ensure compliance with applicable standards. Experience in Oncology submissions is essential, although the Client has a varied and extensive portfolio for other indications also.



This is a 100% home-based role. We are offering a 12-month fixed-term contract with the possibility of transitioning to a permanent role based on performance and business needs.



Key Responsibilities:

• Assist in preparing the full portfolio of necessary study documentation, including completion of all necessary forms within Combined Review, with specific expertise, focus and attention to detailing of drugs appropriately within forms similar to the old core EudraCT Forms (Annex I, II, & III), cover letters, and other regulatory materials.


• Complete and confidently review/QC the Medicines Information Form, with particular attention to Section D9, for IRAS/Combined Review submissions.


• Ideal candidate will also have knowledge and experience in completion of relevant submissions to the REC/ HRA & ARSAC, although this aspect can be developed.


• Prepare Amendments and submit routine documents to Regulatory Authorities and REC/HRA, taking ownership of specific pieces of work as required.


• Coordinate the collection and organization of data required by Regulatory Authorities.


• Participate in client and team meetings and proactively liaise with clients regarding regulatory submission matters.


• Effectively manage and track all activity related to Clinical Trials submissions including preparation of filing packages for the TMF.


• Perform QC of other team member’s packages prior to Submission.


• Collaborate with other internal teams as required to produce and submit regulatory documents.


• Maintain an up-to-date understanding of regulatory guidelines and legislation related to drug and biologic products.


• Monitor compliance with regulatory requirements and timelines on assigned projects.


• Take part in special regulatory projects and other duties as assigned.

Qualifications:

• Bachelor’s Degree in Life Sciences or equivalent field.


• Fortrea may consider relevant and equivalent experience in lieu of educational qualifications.

Experience:

• A minimum of 2 years of experience in the pharmaceutical industry, preferably in Regulatory Affairs or Drug Development.


• Proven experience with the Medicines Information Form, particularly with Section D9, within the IRAS/Combined Review process.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.



Fortrea is proud to be an Equal Opportunity Employer:



As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.



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