SENIOR REGULATORY SCIENTIST - ICON - Paris, France / Home-Based
(2024-04)
Provide regulatory oversight and strategic input across clinical trial regulatory activities, supporting country-level submission planning, regulatory compliance, authority engagement, risk management and successful progression of regulatory deliverables through submission and approval.
- Provide strategic input into regulatory submission planning, proactively identifying country-level regulatory risks and contributing to appropriate mitigation strategies.
- Manage and coordinate clinical trial regulatory deliverables in accordance with applicable regulations, guidelines, policies, contractual requirements, timelines and budgets.
- Serve as a regulatory interface with Regulatory Authorities, Central Ethics Committees and other country-level bodies, supporting regulatory interactions and resolution of country-specific requirements.
- Manage regulatory activities for early phase studies in the Netherlands and Hungary
- Coordinate the preparation, adaptation, collation and submission of regulatory documentation in accordance with applicable country requirements.
- Arrange and perform quality-control reviews of regulatory submission documentation to ensure completeness, accuracy and compliance with project requirements.
- Manage country and regional clinical trial documentation through submission and approval, maintaining accurate records across CTMS, eTMF and other applicable systems.
- Provide country-specific regulatory consultancy to clients and project teams, supporting interpretation of local requirements and addressing regulatory questions.
- Support maintenance of accurate and current country regulatory intelligence, contributing relevant regulatory developments and requirements to project teams.
- Coordinate regulatory activities related to clinical trial labeling, including regulatory compliance checks, translation verification and quality control.
- Support country-level import/export licensing activities and review country-specific insurance documentation for regulatory compliance.
- Maintain accurate tracking of regulatory submission and approval progress across applicable clinical and regulatory systems.
REGULATORY AFFAIRS ASSOCIATE - ICON - Paris, France
(2022-12 - 2024-04)
Provided regulatory consulting and submission support across international clinical development programs, with responsibility spanning early- and late-phase studies across multiple European markets.
- Provided Regulatory Affairs consulting to clients and internal project teams, responding to country-specific regulatory questions and supporting interpretation of applicable requirements.
- Managed regulatory activities for late-phase studies in France and Spain.
- Coordinated initial, amendment and other central-authority approvals involving Regulatory Authorities, IECs and other applicable bodies.
- Managed country-level regulatory activities supporting the import and, where applicable, export of Investigational Products and clinical trial supplies.
- Managed country-level informed consent and patient-facing documentation through preparation, submission and approval.
- Ensured Investigational Product labeling complied with applicable country requirements.
- Served as Local Reviewer within quality-control processes, reviewing regulatory documentation against applicable requirements.
- Mentored junior team members, supporting knowledge development and quality execution within the Regulatory Affairs function.
- Maintained country regulatory knowledge repositories and contributed to regulatory intelligence collection, maintenance and communication.
- Supported preparation and review of GMP and product submissions involving drug products and medical devices, including maintenance activities, labeling and promotional materials, with appropriate oversight.
- Tracked and reported regulatory submission and approval progress through CTMS, eTMF and other applicable systems.
PROJECT MANAGER, CLINICAL RESEARCH - UNIVERSITY HOSPITAL MONTPELLIER - Montpellier, France
(2021-10 - 2022-12)
Managed international clinical research programs spanning regulatory, operational, financial and stakeholder-management activities across France, Spain and the United States.
- Managed two international clinical trials across France, Spain and the USA, coordinating regulatory and operational activities across multiple stakeholders.
- Coordinated regulatory submissions to French competent authorities and supported preparation of FDA submission packages.
- Managed CRA monitoring resources and coordinated activities involving a Spanish CRO, Events Committee and Data and Safety Monitoring Board (DSMB).
- Managed study budgets, including budget revisions, site payments and contract negotiations.
- Coordinated regulatory amendments and updates to study documentation, including informed consent forms, protocols, synopses and patient-facing materials.
- Led recurring project meetings and prepared formal meeting reports to maintain alignment across study stakeholders.
- Collaborated with sponsors and investigational sites to support study requirements and clinical trial execution.
- Coordinated monitoring activities, including initiation, interim and close-out activities.
CLINICAL RESEARCH ASSOCIATE (CRA) - UNIVERSITY HOSPITAL MONTPELLIER - Montpellier, France
(2020-01 - 2021-10)
- Conducted clinical trial monitoring activities across initiation, interim and close-out stages.
- Supported regulatory amendment activities and coordination with investigational sites and clinical research stakeholders.
- Led recurring meetings with coordinating teams and investigational sites.
- Supported clinical trial execution, documentation and monitoring requirements across study activities.
- Collaborated with sponsors, responding to requests, supporting monitor visits and participating in sponsor meetings.
STUDY COORDINATOR | NEUROLOGY DEPARTMENT - UNIVERSITY HOSPITAL MONTPELLIER - Montpellier, France
(2017-11 - 2020-01)
- Coordinated activities across 20 observational and interventional clinical trials involving drugs, medical devices and other study types.
- Supported feasibility activities and study initiation, monitoring and close-out visits.
- Managed study planning, Investigational Product accountability and traceability of biological samples.
- Coordinated SAE reporting and other study-management activities.
- Developed Standard Operating Procedures (SOPs) to strengthen completeness and quality of clinical trial data.
- Collaborated with sponsors, monitors and investigational sites throughout study execution.
- Contributed to development of the rare-disease competence center designation.
