Regulatory Affairs Assiociate

.11 drugs developed. 6 million courses of treatment. Immeasurable lives improved. Regulatory Affairs Associate £38,000 - £43,500 plus Reports to: Senior Regulatory Affairs Manager (Team Lead) Directorate: Research & Innovation Contract: 12 month fixed-term contract Hours: Full time 35 hours per week, (flexible working requests considered) Location: Stratford, London Office-based with high flexibility (1-2 days per week in the office). We're happy to offer home-based contracts through our flexible working policy. While this role does involve occasional travel to our Stratford Office - typically 4 to 6 times a year, please note that travel expenses are not covered. We aim to keep travel minimal and purposeful, ensuring it adds real value to your work and team collaboration. Closing date: 10th May 23:55pm Recruitment process: Screening call followed by competency-based interview via MS Teams. Please note: You must be eligible to work in the UK to apply for this vacancy. Cancer Research UK is not able to offer visa sponsorship. At Cancer Research UK, we exist to beat cancer. Cancer Research UK are looking for a proactive, ambitious and meticulous Regulatory Affairs Associate to join the Regulatory Affairs team that sits within the Centre of Drug Development at Cancer Research UKThe Cancer Research UK Centre for Drug Development (CDD) is the world's only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in.The Regulatory Affairs Associate will work as part of the wider Regulatory Affairs team to prepare and submit regulatory documents to facilitate the successful execution of Cancer Research UK (CRUK) clinical trials. You'll work to all policies and procedures, ensuring compliance with current clinical trial legislation.This is a great opportunity to work as part of a multidisciplinary team on early phase oncology trials, giving you the chance to gain a broad range of experience across the process. You'll also be surrounded by people as dedicated to beating cancer as you. Work with the Regulatory Affairs Manager (RAM)/Senior RAM (Team Lead) in the preparation and submission of initial clinical trial authorisation (CTA) and subsequent modifications/notifications to the UK and EU regulatory agencies as required for each of the designated projects. Act as internal regulatory representative on designated projects with support from RAM/Senior RAM (Team Lead), attending project and study team meetings and providing general regulatory guidance to project/study teams. Lead discussion around regulatory strategy for designated projects, agreeing documentation requirements for initial applications, classification of modifications and document updates required with support from RAM/Senior RAM (Team Lead). Lead the production and review of Investigational Medicinal Product Dossiers (IMPD) for designated projects with support from RAM/Senior RAM (Team Lead), writing sections, liaising with other members of the Internal Project Team, external manufacturing organisations and third-party contacts as appropriate to finalise the document. Prepare/review additional CTA documents as required for designated projects and as requested by the RAM/Senior RAM (Team Lead). Prepare modifications and notifications for designated projects and as requested by the RAM/Senior RAM (Team Lead). Register and maintain new products for CDD projects within the Extended EUDRAVIGILANCE Medicine Product Dictionary (XEVMPD) when required Support the Regulatory Team when requested in tasks as agreed by the Senior Regulatory Manager (Team Lead) including but not limited to; maintenance of regulatory section of designated projects in the Trial Master File (TMF), TMF reviews, updating and maintenance of regulatory database, monitoring general regulatory email address for contacts/queries, review and QC of regulatory documents/submission packages. What are we you looking BSc. (Hons) qualification in a scientific discipline (or equivalent level of experience) Highly computer literate (extensive experience of standard Microsoft packages) Previous experience in the pharmaceutical industry (or equivalent), ideally in a regulatory capacity Familiarity with ICH/GCP guidelines, the UK and EU Clinical Trials legislation Good understanding of the drug development process and clinical trials Excellent interpersonal and communication (both written and verbal) skills and able to engage with diverse audiences Attention to detail/accuracy Ability to work independently and as part of a team Experience of preparing and reviewing regulatory documents for submission to UK and EU regulators - desirable Experience of first in human and/or early phase oncology trials - desirableOur organisation values are designed to guide all that we do. Bold: Act with ambition, courage and determination Credible: Act with rigour and professionalism Human : Act to have a positive impact on people Together: Act inclusively and collaboratively We're looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer.If you're interested in applying and excited about working with us but are unsure if you have the right skills and experience we'd still love to hear from you.We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities and high-quality tools. Our policies and processes enable you to improve your work-life balance, take positive steps in your career and achieve your personal wellbeing goals.You can explore our benefits by visiting our .We operate an anonymised shortlisting process in our commitment to equality, diversity and inclusion. CVs are required for all applications; but we won't be able to view them until we invite you for an interview. Instead, we ask you to complete the work history section of the online application form for us to be able to assess you fairly and objectively. For more information on this career opportunity please or contact us at more updates on our work and careers, follow us on: and .Our vision is to create a charity where everyone feels like they belong, benefits from and participates in, the work we do. We actively encourage applications from people of all backgrounds and cultures, in particular those from ethnic minority backgrounds who are currently under-represented.We want to see every candidate performing at their best throughout the job application process, interview process and whilst at work. We therefore ask you to inform us of any concerns you have or any adjustments you might need to enable this to happen. Please contact or 0 as soon as possible. Unfortunately, we are unable to recruit anyone below the age of 18, so that we can protect young people from health & safety and safeguarding risks.