Regulatory & Start-Up Specialist, IQVIA Biotech, UK Homebased IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster. Job Overview We are seeking a highly motivated Regulatory & Start-Up Specialist to support clinical trial site activation activities across the UK. In this role, you will play a pivotal part in ensuring studies are initiated efficiently, compliantly, and in alignment with regulatory requirements, SOPs, and project timelines. You will collaborate cross-functionally and act as a key liaison between sites, project teams, and internal stakeholders, contributing to the successful delivery of clinical trials.

Key Responsibilities

Act as the Single Point of Contact (SPOC) for assigned studies, supporting investigative sites, Site Activation Managers (SAMs), Project Management, and internal teams Deliver site start-up and activation activities in compliance with local and international regulations, SOPs, and work instructions Prepare and review regulatory documentation, ensuring completeness, accuracy, and timely submission Maintain and update internal systems, databases, and tracking tools with study-specific information Monitor site performance and provide feedback on metrics and deliverables Support study start-up timelines, identifying risks and implementing contingency plans as required Track and follow up on the progress of regulatory approvals, ethics submissions, contracts, ICFs, and Investigator Pack (IP) releases Ensure timely distribution of approved documents to sites and project teams Provide local regulatory expertise to study teams during planning and execution phases Perform quality control checks on site documentation Build effective relationships with stakeholders, including occasional interaction with sponsors Required Qualifications & Experience Bachelor’s degree in Life Sciences or a related field Minimum 3 years of clinical research experience Strong understanding of clinical systems, processes, and corporate standards Sound knowledge of GCP/ICH guidelines and regulatory requirements Experience within a regulated clinical trial environment and understanding of the drug development lifecycle Skills & Competencies Excellent communication and stakeholder management skills Strong organizational and multitasking abilities Ability to work independently and prioritize effectively across multiple projects Confident in negotiation and influencing, with the ability to challenge constructively Detail-oriented with a strong focus on quality and compliance Ability to build and maintain collaborative relationships with internal and external stakeholders Why Join Us? Be part of a dynamic and collaborative clinical research environment Contribute to innovative studies that improve patient outcomes Access to career development and growth opportunities Work alongside experienced professionals in a global organization IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.