Clinical Trials Regulatory Officer
Guarda esta oferta y sigue tu búsqueda
Crea una cuenta gratis para guardar empleos, crear alertas y volver a esta oferta desde tu panel.
Al continuar, aceptas nuestros Términos & Política de Privacidad.
This position is at IQVIA The selection process will be entirely managed by IQVIA.
-- Clinical Trials Regulatory Officer 2 (Regulatory Maintenance Associate) Job Overview The Clinical Trials Regulatory Officer 2 (Regulatory Maintenance Associate) is responsible for managing regulatory activities for maintenance studies, ensuring compliance with applicable regulations, guidelines, and company processes.
The role focuses on preparing and maintaining global core clinical trial submission dossiers, supporting EU Clinical Trials Regulation (CTR) modifications, and providing regulatory guidance for ongoing clinical trials.
This position requires effective collaboration with internal and external stakeholders to ensure timely, accurate, and compliant regulatory deliverables throughout the study lifecycle.
Key Responsibilities Prepare, review, and maintain global core clinical trial submission dossiers in accordance with regulatory requirements and company standards.
Support the preparation and submission of maintenance-related regulatory filings, amendments, and modifications, including EU CTR submissions through CTIS.
Ensure regulatory documentation remains current, accurate, and compliant throughout the lifecycle of assigned studies.
Provide regulatory guidance and strategic input to project teams and clients regarding maintenance study requirements and submissions.
Partner with internal and external stakeholders to support regulatory deliverables and study objectives.
Develop a clear understanding of project scope, timelines, deliverables, and budget considerations to ensure successful execution.
Monitor regulatory activities and proactively manage timelines to meet project milestones and client expectations.
Maintain internal systems, databases, regulatory tracking tools, and project plans with a high level of accuracy and attention to detail.
Support quality and compliance initiatives by ensuring documentation is inspection and audit ready.
Identify regulatory risks, communicate concerns appropriately, and contribute to the development of effective solutions.
Qualifications
-
Senior Medical Writer: Clinical Trials
Hace 2 días
Madrid, Madrid, España IQVIA Jornada completaIQVIA is seeking a senior Medical Writer to deliver high-quality clinical documents for eye health and inflammatory indications. You will integrate with sponsor teams, manage timelines, and ensure adherence to regulatory requirements across ICH, FDA, and EMA guidelines.The role emphasizes senior-level writing leadership, collaboration across disciplines, and...
-
Spain-based Regulatory
Hace 9 horas
madrid, comunidad de madrid, España Precision Medicine Group Jornada completaPrecision Medicine Group in Madrid, Spain, is seeking a Regulatory and Start Up Specialist for an on-site role. You will drive site activation, prepare CTAs and submission dossiers, and liaise with authorities and ethics committees to obtain approvals in line with ICH-GCP and local requirements. The ideal candidate will have CRO/pharma experience, strong...
-
Spain-based Regulatory
Hace 3 días
Madrid, Madrid, España Precision Medicine Group Jornada completaPrecision Medicine Group in Madrid, Spain, is seeking a Regulatory and Start Up Specialist for an on-site role. You will drive site activation, prepare CTAs and submission dossiers, and liaise with authorities and ethics committees to obtain approvals in line with ICH-GCP and local requirements.The ideal candidate will have CRO/pharma experience, strong...
-
Regulatory Compliance Officer
Hace 4 días
Madrid, Area Metropolitana (comarca); Comunidad de Madrid, España Precision for Medicine Jornada completaPrecision for Medicine is seeking a Regulatory and Start Up Specialist based in Madrid to drive country/site activation for clinical trials. You will prepare submissions, interact with authorities and ethics committees, and coordinate with regulatory, clinical operations, and contracts teams to ensure timely approvals. You should have a life sciences...
-
Project Manager Clinical Trials
Hace 3 días
Comunidad de Madrid, Comunidad de Madrid, España Allucent Jornada completaAt AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Project Manager (Sr. PM) to join our A-team (hybrid*/remote). As a Sr. PM at Allucent, you are responsible for the overall...
-
Madrid, Madrid, España Leapcure Jornada completaJob SummaryWe are seeking a Hematologist - Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as...
-
Clinical Trials Project Lead — Associate Pm
Hace 2 días
Madrid, Madrid, España Icon Strategic Solutions Jornada completaICON Strategic Solutions is seeking a Project Planner to support sponsor-dedicated models with ICON's global expertise and to contribute to the development of treatments that benefit patients worldwide.As an Associate Project Manager, you will help coordinate clinical trials, participate in study design, data collection, and regulatory submissions, and...
-
Madrid, Madrid, España OPIS s.r.l. Jornada completaOPIS s.R.L. is seeking a Clinical Research Associate to monitor and manage multi-country clinical trials, ensuring compliance with study protocols, ICH-GCP, and regulatory requirements.This role emphasizes site initiation, monitoring visits, data quality, and patient safety, reporting to the Clinical Project Manager. The successful candidate will have a...
-
Clinical Drug Safety Officer
Hace 2 días
Madrid, Madrid, España Grifols, S.A Jornada completaWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Madrid, Madrid, España Worldwide Clinical Trials Jornada completaWorldwide Clinical Trials in Madrid is seeking a Senior Site Contracts Specialist to lead negotiation and finalization of clinical trial site contracts and budgets. You will act as a SME on CTA processes at country and site level, coordinating with sponsors, sites and internal teams.The role requires deep knowledge of ICH-GCP, regulatory requirements, and...
