Ban Diana

Regulatory Affairs professional with 9 years of progressive experience across clinical research, clinical trial management and Regulatory Affairs, including regulatory submission management and country-level regulatory activities across France, Spain, the Netherlands and Hungary, with additional exposure to U.S. FDA submission requirements. Currently serving as Senior Regulatory Scientist at ICON, providing strategic input into regulatory submission planning, regulatory risk identification and mitigation, health authority and ethics committee interactions, submission coordination, quality oversight, regulatory intelligence and country-specific regulatory consultancy.

Brings complementary clinical development and project leadership experience, including management of two international clinical trials spanning France, Spain and the United States, CRA coordination, CRO and committee management, sponsor engagement, budget management and FDA submission package preparation. Additional experience includes supporting GMP and product submissions involving drug products and medical devices, regulatory labeling activities and maintenance of country-specific regulatory knowledge.

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.

MASTER'S DEGREE - MANAGEMENT OF CLINICAL TRIALS - University of Montpellier, France (2018)

BACHELOR'S DEGREE - PHYSIOLOGY & NEUROSCIENCES - University of Montpellier, France (2016)