The Clinical Trials Regulatory Officer prepares, reviews, and manages regulatory documentation to support clinical trial submissions in compliance with applicable regulatory requirements. The role provides regulatory support across clinical trial projects, ensuring high-quality deliverables, adherence to timelines, and effective collaboration with internal and external stakeholders.
Key Responsibilities
Prepare and review regulatory documents for clinical trial submissions.
Act as Clinical Trial Regulatory Manager (CTRM) on straightforward projects and support complex projects under senior guidance.
Review scientific and regulatory documentation, conduct gap analyses, and provide recommendations to stakeholders.
Prepare, compile, and maintain clinical trial submission dossiers in accordance with regulatory requirements.
Provide regulatory guidance and strategic input to internal teams and external clients.
Support local, regional, and global clinical trial submissions, including European centralized submissions where applicable.
Ensure project deliverables are completed within scope, budget, and agreed timelines.
Maintain high quality standards across all regulatory deliverables.
Ensure accurate maintenance of systems, databases, tracking tools, and project documentation in line with SOPs.
Participate in project and system audits as required.
Perform additional duties as assigned by the Line Manager.
Qualifications & Experience
Bachelor's degree in Life Sciences, Pharmacy, Health Sciences, or a related field.
2 - 3 years experience in clinical trial regulatory affairs, clinical research, or regulatory submissions.
Knowledge of GCP, clinical trial regulations, and regulatory submission processes.
Strong organizational, communication, and stakeholder management skills.
Ability to manage multiple priorities while maintaining accuracy and quality.
Key Competencies
Attention to detail
Regulatory and scientific review skills
Project management
Client focus
Quality and compliance mindset
Collaboration and teamwork
Effective communication skills
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.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
