Regulatory Specialist

Description

Summary: The Regulatory Specialist coordinates, prepares, and reviews clinical regulatory documents, ensuring compliance with local laws and regulations for clinical studies. Highlights: 1. Manage coordination, preparation, and review of clinical regulatory documents 2. Support study startup and maintain regulatory and ethics approvals 3. Provide regulatory guidance and ensure compliance with applicable regulations ### **Opportunity Details** On Assignment **Regulatory Specialist** Remote \- Argentina The Regulatory Specialist is responsible for managing the coordination, preparation, and review of clinical regulatory documents, including the tracking and reporting of key performance by site and study. prepares and/or reviews submissions for clinical studies to local or central IRB/EC and regulatory authorities, as appropriate, in an ongoing manner maintaining compliance with local state/province or country laws and regulations. Responsibilities: * Supports study startup and regulatory activities, including but not limited to obtaining and maintaining regulatory and ethics approvals * Creates master\-level regulatory package for submissions for Regulatory Agencies * Supports in\-house regulatory submission(s) to Regulatory Agencies * Supports creation of startup plans and essential documents checklists for assigned studies * Prepares ongoing submissions and periodic notifications required by central and local IRB/EC, regulatory authorities, and other local regulatory authorities as needed; includes safety notifications as required by local laws/guidelines * Reviews Master Informed ICFs to ensure all country\-specific requirements are met * Supports the development of country\-specific ICFs as required by the protocols, utilizing translation vendors as necessary * Creates essential document packages to sites and checks for completion * Supports site submissions to local IRBs (provides site packages submits to central IRB) * Confirms greenlight for site activation * Initiates performance tracking (risk mitigation, corrective actions, lessons learned) for study * Participates in study team meetings and provides start up status and regulatory approval updates * Provides regulatory guidance to ensure compliance with applicable regulations and requirements * Escalates regulatory, timeline, or other concerns to study team * Maintains continuous awareness of local/country agency changes in regulatory processes, timelines, and required documentation * Supports study teams during internal study audits and/or other process improvement activities * Supports study teams for and/or during mock and actual inspections by regulatory authorities Education and Requirements * Bachelor’s Degree in a related field, or equivalent combination of training, education, and work experience * At least 3 years of experience in a regulatory role in a pharmaceutical or CRO environment * Extensive experience as site regulatory coordinator a plus * Previous administrative work experience, preferably in an international clinical research setting * Extensive knowledge of FDA GCP\-ICH Guidelines and local regulatory requirements * Ability to demonstrate a high level of competency relating to administrative and clerical responsibilities, procedures, and systems * Ability to handle confidential information and materials in an appropriate manner, and in accordance to organizational policy, proper business practice, and/or appropriate external regulation/governance