Sofia, Sofia-City, Bulgaria · Remote OK
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Barcelona, Catalonia, Spain · Hybrid
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Barcelona, Catalonia, Spain · On-site
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Dijon, Bourgogne – Franche-Comté, France · Hybrid
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Barcelona, Catalonia, Spain · Remote Solely
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Barcelona, Catalonia, Spain · On-site
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Barcelona, Catalonia, Spain · Hybrid
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Barcelona, Catalonia, Spain · On-site
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Barcelona, Catalonia, Spain · Hybrid
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Barcelona, Catalonia, Spain · Remote OK
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Barcelona, Catalonia, Spain · Hybrid
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Worldwide Clinical TrialsBarcelona, Catalonia, Spain · Remote Solely
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Barcelona, Catalonia, Spain · On-site
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Barcelona, Catalonia, Spain · On-site
As an Enterprise AI Value Strategist, you advise clients on how to create and capture value from AI and data. You define enterprise, industry-specific and function-specific AI and data strategy, develop value cases and r…
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Barcelona, Catalonia, Spain · Hybrid
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Barcelona, Catalonia, Spain · Hybrid
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Barcelona, Catalonia, Spain · Hybrid
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Barcelona, Catalonia, Spain · On-site
Description: As an Administrative Assistant based in our Barcelona Office, you will be part of a dynamic, international team of professionals focused on assisting employees in our Front Office (Underwriting Department). …
Skills: Administrative support, Underwriting support, Travel arrangement, Expense reporting, Reception duties
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The role involves providing regulatory oversight and strategic guidance for clinical trial submissions across global programs. Responsibilities include authoring regulatory documentation, managing submission timelines, and ensuring compliance with regulatory requirements.
Candidates must hold a bachelor's degree in Life Sciences, Pharmacy, or a related field. A minimum of 3–5 years of experience in Regulatory Affairs within the pharmaceutical or clinical research industry is required.
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.
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.
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.
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.
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.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US
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