Associate Clinical Trials Regulatory Manager
EMEA
Homebased
Job Summary
The Associate Clinical Trials Regulatory Manager provides regulatory support and oversight for clinical trial submissions across global programs. This role is responsible for preparing and reviewing regulatory documentation, managing submissions, ensuring regulatory compliance, and supporting clients and internal stakeholders throughout the clinical trial lifecycle. This is not a people manager role, but a process management position.
Key Responsibilities
Serve as the Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects and programs.
Provide regulatory oversight and strategic guidance to internal and external stakeholders.
Review scientific and regulatory documentation, conduct gap analyses, and provide recommendations.
Author and/or review key regulatory documents, including Investigational Medicinal Product Dossiers (IMPDs) and clinical trial justifications.
Coordinate and support European centralized submissions and global country submissions.
Ensure project deliverables are completed on time, within scope, and in compliance with regulatory requirements.
Maintain accurate records in internal systems, databases, and tracking tools in accordance with SOPs.
Support business development activities by providing regulatory expertise.
Deliver regulatory training and presentations as required.
Mentor junior team members and contribute to departmental knowledge sharing initiatives.
Qualifications and Experience
Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
Typically 3–5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, CRO, or clinical research industry.
Experience supporting clinical trial submissions and regulatory documentation.
Strong scientific writing, document review, project management, and stakeholder engagement skills.
Advanced knowledge of clinical trial regulations and regulatory submission processes.
Knowledge & Competencies
Advanced knowledge of regulatory affairs and clinical trial submission requirements.
Strong analytical and problem-solving skills.
Excellent communication and collaboration abilities.
Ability to work independently and manage multiple priorities in a fast-paced environment.
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.
Skills Required
- Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field
- 3-5 years' experience in Regulatory Affairs within pharmaceutical, biotechnology, CRO, or clinical research industry
- Experience supporting clinical trial submissions and regulatory documentation (IMPDs, clinical trial justifications)
- Advanced knowledge of clinical trial regulations and regulatory submission processes, including European centralized submissions
- Strong scientific writing, document review, project management, and stakeholder engagement skills
- Ability to work independently, manage multiple priorities, and maintain accurate records per SOPs
IQVIA Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
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Retirement Support — Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
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Leave & Time Off Breadth — Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.
IQVIA Insights
What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
